The National Alliance of Advocates
for Buprenorphine Treatment
Buprenorphine (Suboxone®, Subutex®) is an opioid medication used to treat opioid
addiction in the privacy of a physician's office.1 Buprenorphine can be dispensed
for take-home use, by prescription.1 This, in addition to the pharmacological
and safety
profile of buprenorphine, makes it an attractive treatment for patients addicted to opioids.2
References
Item 1 – Reduces cravings and withdrawal symptoms in opioid dependent people.
"…By week 4 of the study, the average craving scores fell by half for both medication groups (Suboxone & Subutex) but did not change for the placebo group. Patients receiving medications reported greater improvement in overall health and well-being than those in the placebo…" Successful Trial Caps 25-Year Buprenorphine Development Effort By Arnold Mann, NIDA NOTES. Volume 19, Number 3 (September 2004) page 3, paragraph 5 http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf
"…Buprenorphine reduces or eliminates withdrawal symptoms associated with opioid dependence but is not strong enough to produce the euphoria and sedation caused by heroin or other opiates…" Buprenorphine Approval Expands Options for Addiction Treatment,NIDA NOTES, Volume 17, Number 4 (November 2002) Page18, paragraph 1 http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf
"…Both (Suboxone and Subutex) block the effects of opiates while reducing opiate cravings and easing withdrawal symptoms…" Intelligence Bulletin: Buprenorphine: Potential for Abuse; DEA http://www.usdoj.gov/ndic/pubs10/10123/ (Doc. ID: 2004-L0424-013, paragraph 3)
"…At low doses Buprenorphine produces sufficient agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms…"About Buprenorphine Therapy, Applied Pharmacology,U.S. Department of Health & Human Services, Substance Abuse & Mental Health Services Administration (SAMHSA) http://buprenorphine.samhsa.gov/about.html
"Buprenorphine blocks the effects of other opiates and eliminates cravings and symptoms of withdrawal." http://www.cumc.columbia.edu/dept/bup/buprenorphine_glossary.htm
"Buprenorphine has relatively mild withdrawal symptoms, and a treatment schedule that does not require daily dosing could significantly increase the number of heroin users seeking treatment" Buprenorphine Taken Three Times per Week Is as Effective as Daily Doses in Treating Heroin Addictionby Patrick Zickler, NIDA Notes - Volume 16, Number 4 (October 2001), page 19, paragraph 2. http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf
"Buprenorphine, a partial opioid agonist, reduces withdrawal symptoms and blocks the effects of subsequently administered opioids..." http://www.drugabusehelp.com/drugs/buprenorphine/ (paragraph 3.)
"…eliminates the major motivation for opiate abuse by preventing withdrawal symptoms such as pain, chills, nausea, and opiate cravings."Columbia Buprenorphine Program for Opiate Maintenance and Detoxification http://www.nyppsychiatry.org/cli_ser_col_bup.html?name1=NewYork-
Presbyterian+Psychiatry+Alphabetical+Services&type1=2Select (paragraph 2
"Buprenoprphine…lower abuse potential, lower level of physical dependence(less withdrawal discomfort)…" Buprenorphine: A New Treatment Option for Opioid Addiction U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40)p. 6, col 2, paragraph 3
Clinical Psychiatry News, June 2005 v33 i6 p47(1) Buprenorphine combo aids detoxification. (Addiction Psychiatry) Carl Sherman.
Buprenorphine: A New Treatment for Opioid Addiction Harvard Mental Health Letter, Feb 2001 v17 i8 pITEM01046003
Johnson, RE, et al. "A Comparison of Levomethadyl Acetate, Buprenorphine, and Methadone for Opioid Dependence,"New England Journal of Medicine (November 2, 2000): Vol. 343, No. 18, pp. 1290-97.
O’Connor, PG. "Treating Opioid Dependence - New Data and New Opportunities," New England Journal of Medicine (November 2, 2000): Vol. 343, No. 18, pp. 1332-1335.
Kakko, Johann, et al. "1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a andomised, placebo controlled trial." Lancet 2003; 361: 662-68.
"…buprenorphine produces sufficient agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms" Buprenex, Subutex, and Suboxone Opiate Detox for Heroin and Opiate Dependence http://www.drug-rehabilitation.com/opiate-detox.htm (paragraph 5
"It can speed ‘detoxification’ (going from daily use to no use) and reports are that it can take users from extremely heavy levels of dependence to zero without serious withdrawal." Buprenorphine Approved by US FDA for Opiate Addiction Treatment, Originally Published in TRIP by JG, October 8, 2002, paragraph 3. http://www.erowid.org/pharms/buprenorphine/buprenorphine_info1.shtml
Item 2 – "Abuse" resistant– does not produce strong euphoria like other opioids, likely to cause withdrawal if misused.
"…combination tablet of buprenorphine and naloxone that would minimize the potential for abuse…"Successful Trial Caps 25-Year Buprenorphine Development Effort By Arnold Mann, NIDA NOTES Volume 19, Number 3, September 2004, page 2, paragraph 4 http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf
Fudala, P.J., et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone.New England Journal of Medicine 349(10):949-958, 2003.
Sobel, B.F.; Sigmon, S.C.; et al. Open-label trial of an injection depot formulation of buprenorphine in opioid detoxification.Drug and Alcohol Dependence 73(1):11-22, 2004.
"Buprenorphine reduces or eliminates withdrawal symptoms associated with opioid dependence but is not strong enough to produce the euphoria and sedation caused by heroin or other opiates." Buprenorphine Approval Expands Options for Addiction Treatment NIDA Research Findings - Volume 17, Number 4 (November 2002), page 14, paragraph 1
"…with several clinically desirable pharmacologic properties: lower abuse potential, less withdrawal discomfort…" Buprenorphine: A New Treatment Option for Opioid ddiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), p. 6, col 2, paragraph 2.
"…abuse potential appears substantially less …"Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), p. 8, col 2, paragraph 1.
"Buprenorphine has a potential for abuse less than the drugs or other substances in Schedules I and II." Federal Register: October 7, 2002 (Volume 67, Number 194) Rules and Regulations, Page 62354-62370
From the Federal Register Online via GPO Access [wais.access.gpo.gov] DOCID:fr07oc02-13 http://www.deadiversion.usdoj.gov/fed_regs/sched_actions/2002/fr1007.htm
"Buprenorphine is used as a pain reliever and to treat opiate addiction. It produces less of a "high" than other opioids, such as codeine and morphine. For this reason, it is less susceptible to abuse and may be easier to stop taking." http://drugabusehelp.com/drugs/buprenorphine/ (paragraph 7)
"At low doses buprenorphine produces sufficient agonist effect to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms" SAMSHA website http://buprenorphine.samhsa.gov/about.html (paragraph 4
"... as a partial opioid agonist, buprenorphine reduces withdrawal symptoms and blocks the effects of subsequently administered opioids." http://drugabusehelp.com/drugs/buprenorphine/
"Buprenorphine…, it has a relatively low abuse potential when compared to full opiate agonists such as oxycodone, heroin, and morphine... a much lower potential for abuse."Buprenorphine and Buprenorphine/Naloxone: New Treatment for Opiate DependenceCounselor, The Magazine for Addiction Professionals, August 2004, v.5, n.4, pp. 52-55. http://www.counselormagazine.com/display_article.asp?aid=aug04Buprenorphine.htm (paragraph 1)4
"The combination of buprenorphine with the opiate antagonist naloxone would significantly reduce the potential of this medication for abuse."Bringing the Power of Science to Bear on Drug Abuse and Addiction - Five Year Strategic Plan (2000-2005), NIDA Strategic Plan, Strategy 2: Develop and Distribute Tools To Improve the Quality of Drug Abuse Treatment Nationwide. See inset. http://www.nida.nih.gov/StrategicPlan/Strategy2.html,
"…drugs such asSuboxone, Subutex, and Bupenorphinecan make detox relatively pain-free." What is withdrawal? How long does it last? Alcohol and Drug Detox Centers http://www.thetreatmentdirectory.com/detox-centers.html (paragraph 2
"Buprenorphine has proven effective in minimizing the extremely painful side effects of opiate withdrawal without patients feeling either euphoria or sedation." http://www.serenitylane.org/buprenorphine.html (paragraph 2
"…buprenorphine is a partial opioid receptor agonist. This gives buprenorphine the ability to relieve the symptoms of opioid withdrawal without producing the euphoria of the full agonist drugs…" http://www.soberliving.com/suboxone.htm (paragraph 4
"Buprenorphine does produce an opiate euphoria, but the high is so mild it’s barely perceptible."Under My Tongue; The new face of the anti-addiction drug buprenorphine — safer, easier and FDA-approved, by Steven Kotle, LA Weekly, August 22-28, 2003 http://www.laweekly.com/ink/03/40/features-kotler.php paragraph 4
"Because buprenorphine is a partial opioid agonist, its opioid effects, such as euphoria… reach a ceiling of maximum effect…" http://www.nyc.gov/html/doh/html/basas/buprenorphine-fact.shtml (paragraph 5
Item 3 – Ceiling effect – cannot achieve a "high" from taking more than prescribed. This means an otherwise healthy person in unlikly to have a fatal overdose on Buprenorphine alone, when taken sublingually.
"…When administered sublingually as Suboxone® and Subutex® are, the maximum effect appears to occur in the 16-32mg range. Even if doses exceed this range, the drug effect plateaus. This is referred to as the ceiling effect." Buprenorphine and Buprenorphine/Naloxone: New Treatment for Opiate Dependence, Counselor, The Magazine for Addiction Professionals, August 2004, v.5, n.4, pp. 52-55. http://www.counselormagazine.com/display_article.asp?aid=aug04Buprenorphine.htm (paragraph 1)0
"Suboxone also exhibits a "ceiling effect" on respiratory depression, thereby decreasing the danger of overdose compared to other opioids." http://drugabusehelp.com/drugs/buprenorphine/ (paragraph 1)5
"…the "ceiling effect." Thus, buprenorphine carries a lower risk of abuse, addiction, and side effects compared to full opioid agonists." http://buprenorphine.samhsa.gov/about.html paragraph 4
"Buprenorpine also has a "ceiling effect" whereby increased doses of the drug do not produce increased effects after a certain point, or ceiling." http://www.usdoj.gov/ndic/pubs10/10123/ (paragraph 1)0
"…buprenorphine exhibits a very high affinity and a very long binding half-life with opioid µ-receptors. It is only a partial agonist for these receptors, meaning that its maximal effect is lower than that of morphine. This is called a ‘ceiling effect.’" Therapeutic Drug Monitoring of High-dose Buprenorphine: Why and How? The International Association for Therapeutic Drug Monitoring and Clinical Toxicology http://www.iatdmct.org/buprenorphine.htm (paragraph 1)
"Because buprenorphine is a partial opioid agonist, its opioid effects, such as euphoria and respiratory depression, as well as its side effects reach a ceiling of maximum effect"NYC Department of Health and Mental Hygiene http://www.nyc.gov/html/doh/html/basas/buprenorphine-fact.shtml (paragraph 5
Kabirullah L., et al, "Buprenorphine-Induced Antinociception Is Mediated by µ-Opioid Receptors and Compromised by Concomitant Activation of Opioid Receptor-Like Receptors",The Journal of Neuroscience, November 12, 2003, 23(32):10331-10337.
Raisch, DW et al., "Opioid dependence treatment, including buprenorphine/naloxone"
Ann Pharmacother 2002; 36: 312-321.
Sporer KA, "Buprenorphine: a primer for emergency physicians." Ann Emerg Med. 2004 May; 43(5):580-4.
"Buprenorphine is a partial opiate agonist… It exhibits a ceiling effect, which means that once a certain receptor occupancy desired dosage level has been achieved, additional dosing does not produce additional effects, including eliminating the typical possible opiate overdose effects…" New York State Office of Alcoholism and Substance Abuse Services, http://www.oasas.state.ny.us/AdMed/meds/buprenorphine.htm (paragraph 1)"Buprenorphine is a partial agonist…its maximal opioid effects are less than that of full agonists, and reach a ceiling where higher doses so not result in increasing effect."
U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), Pharmacology of Buprenorphine Overview, p. 15, column 1, paragraph 1.
"Buprenorphine acts as an opioid agonist with a ceiling effect …" Buprenorphine for the Treatment of Opioid Dependence, University of Montana, School of Pharmacy and Allied Health Sciences Drug Information Services, May 2003, Vol 4 No. 5 page 1, paragraph 2 http://www.spahs.umt.edu/DIS/pdf/buprenorphine.pdf
"Buprenorphine has what’s called a "ceiling effect." Once you’re taking a certain amount of the drug, higher doses don’t produce a greater effect…"Buprenorphine: The New Kid on the Blockby Donna M. Kaminski AIDS Community Research Initiative of America (ACRIA) Update, Spring 2005 - Vol.14 No. 2, Para 5 http://www.acria.org/treatment/treatment_edu_springupdate2005_kid.html
"…these effects are less dose-dependent than those drugs and a ‘ceiling effect’ has been demonstrated for many of the actions of buprenorphine.", Office-Based Therapy for Opiate Addiction Successful.Medical News Today, September 6, 2003 http://www.medicalnewstoday.com/medicalnews.php?newsid=4254 (paragraph 9
"Buprenorphine also has a "ceiling effect" whereby increased doses of the drug do not produce increased effects after a certain point, or ceiling." National Drug Intelligence Center, September, 2003, Effects/paragraph 1, Document ID: 2004-L0424-013 http://www.usdoj.gov/ndic/pubs10/10123/10123t.htm
"…sublingualbuprenorphine produces typicalopioidagonist effects which are limited by a ceiling effect."RxList/Clinical Pharmacology, paragraph 1. http://www.rxlist.com/cgi/generic3/suboxone_cp.htm
"… produces ceiling effect, ex. Buprenorphine",CP Lecture – Substance Abuse III: Treatment, March 8, 2002, Professor Hervert D. Kleber, M.D. page 2, paragraph 5 http://www.cumc.columbia.edu/dept/ps/2005/first_year_docs/CP03-08-02.pdf
Item 4 – Blocking effect – cannot "get high" from using other opiates (heroin, OxyContin®, Vicodin®, etc.) while maintained at appropiate doses of Buprenorphine.
"…its maximal effects are less than those of full agonists like heroin and methadone."http://www.phytomedical.com/Plant/Buprenorphine.asp Clinical Background, paragraph 1.
"Buprenorphine blocks opioid withdrawal and craving without producing a strong narcotic high." http://remedyfind.com/rem.asp?ID=13325 (paragraph 2
"Suboxone, bupe is a synthetic opiate that pushes the same buttons as heroin or painkillers like Vicodin, Percocet, or OxyContin, only without the high or any other significant side effects. It frees recovering addicts from cravings and crashes…" The Bitter Pill From Wired, Copyright 2005 http://www.lightparty.com/Health/BitterPill.html (paragraph 3
Fiellin, D., et al. Consensus statement on office-based treatment of opioid dependence using buprenorphine, Journal of Substance AbuseTreatment 27 (2004) 153– 159
"But for others, buprenorphine can end cravings for street drugs without producing a high, allowing addicts to hold jobs or simply save their lives." Peter DeMarco, Globe Correspondent, Greater access to treatment hailed, TheBoston Globe, August 7, 2005 http://www.boston.com/news/local/massachusetts/articles/
2005/08/07/greater_access_to_treatment_hailed/
"…opiate-dependent individuals who take buprenorphine won’t get any additional kick from using other opiates…" A new treatment for addictionby Etienne Benson, Unique Pharmacology http://www.apa.org/monitor/jun03/newtreat.html (paragraph 5
"Naloxone has been added to Suboxone to guard against intravenous abuse of buprenorphine by individuals physically dependent on opiates."Subutex and Suboxone approved to treat opiod dependence, FDA Talk Paper, T0-38, October 8, 2002 http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01165.html (paragraph 2.)
"…occupying receptors but not activating them while at the same time displacing or blocking full agonists from receptors." Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), p. 12, col 1, Partial Agonists, paragraph 1.
…"buprenorphine helps relieve symptoms of withdrawal while blocking the effects of additional injections of heroin." Two New Drugs Ease Withdrawal from Narcotics http://community.nursingspectrum.com/MagazineArticles/article.cfm?AID=8390 (paragraph 3
Law, F., et al.The clinical use of buprenorphine in opiate addiction: evidence and practice.Acta Neuropsychiatrica. 16(5):246-274, October 2004.
"…buprenorphine will not give an addict more than a mild high no matter how large the dose." New Drug promises Shift in Treatment for Heroin Addicts By Richard Perez-Pena, (New York Times) Late Edition - Final, Section A, Page 1, Column 6
"Buprenorphine is a partial opiate agonist. This can be thought of the key that opens the door, but this time the safety chain is in place. The door opens some, but not all the way. Increasing the dose of partial opiate agonists produces greater effects, but this effect is limited. No matter how fast or with how much force the door is opened, the safety the safety chain remains in place." Antagonists, agonists, and partial agonists, Counselor, The Magazine for Addiction Professionals, August 2004, v.5, n.4, pp. 52-55. http://www.counselormagazine.com/display_article.asp?aid=aug04Buprenorphine.htm (paragraph 4.)
"So not only does it stop cravings, but it prevents you from using other opiates while on it."
An Alternative To Methadone, Legislation may give hope, help to addicts, Laura Wylde, Boise Weekly, August 10, 2005 http://www.boiseweekly.com/gyrobase/Content?oid=oid%3A103017
"Buprenorphine… It does not fully activate the receptors, so users do not get the same high they would with heroin." Law widens access to anti-addiction medication, Shirley Wang, The Philadelphia Inquirer, August 4, 2005.
http://www.philly.com/mld/inquirer/living/health/12297221.htm
Kosten TR, Fiellin DA. Buprenorphine for office-based practice: consensus conference
overview. American Journal on Addictions, 2004;13 (suppl 1):S1-S7.
Fiellin DA, O’Connor PG, Chawarski M, Schottenfeld, RS. Processes of care during a
randomized trial of office-based treatment of opioid dependence in primary care. American Journal on Addictions, 2004;13 (suppl 1):S67-S78.
Item 5 – Favorable safty profile– side effects are similar to, but, milder than, the opioid someone is trying to get off. Does not impair or intoxicate the patient.
"…intensity of side effects may be less than that produced by full agonists opioids"Buprenorphine: A New Treatment Option for Opioid Addiction
U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), p. 18, col 1, paragraph 3.
"It still amazes him how quickly it worked. He didn’t feel high, didn’t feel withdrawal symptoms, didn’t even feel medicated; he just felt better". The Bitter Pill. Wired, April 6, 2005 http://www.lightparty.com/Health/BitterPill.html (paragraph 2
"I’m more clear-headed than I’ve been in years,’’ he said. ‘‘I feel better physically. For the first time in a long time, I can see myself getting off everything in a way that’s not going to rip a hole in my life and leave me only partially functioning."New Drug promises Shift in Treatment for Heroin Addicts. By Richard Perez-Pena, New York Times Late Edition - Final, Section A, Page 1, Column 6
"…ceiling effect adds to its safety in accidental or intentional overdose." Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), p. 18, col 1, paragraph 4.
"…buprenorphine product will produce opioid agonist effects; however, the euphoric effects would be mild" Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), p. 24, col 1, paragraph 2.
" A small percentage of all people on buprenorphine suffer from side effects. Many of these will occur in the first week of treatment and are often due to the combined effect of withdrawal from opioids and taking buprenorphine.Symptoms are often similar to those experienced during buprenorphine withdrawal and may also include headaches…"
http://www.southcityclinic.com.au/hp_bup.htm Side Effects/ paragraph 1
"Opioid addicts will perceive a subjective effect and report "feeling normal."http://www.pharmacy.umaryland.edu/~osas/Downloads/adolescentpcol.pdf slide 25
"Buprenorphine can rarely create some subjective euphoria…" Antagonists, agonists, and partial agonists, Counselor, The Magazine for Addiction Professionals, August 2004, v.5, n.4, pp. 52-55. http://www.counselormagazine.com/display_article.asp?aid=aug04Buprenorphine.htm (paragraph 5
"…does not produce the same high, dependence or withdrawal syndrome." U.S. Department of Health and Human Services. NIDA Research and SAMHSA Physician Training combine to Put Care for Opiate Dependence in Hands of Family Doctor. October 9, 2002. http://www.samhsa.gov/news/newsreleases/021009ma_bupe_wNIDA.htm
"Buprenorphine is used as a replacement drug for heroin, painkillers and other opiates. Subutex is the pure form. Suboxone is a combination tablet of buprenorphine and naloxone. Naloxone was added to prevent addicts from grinding and injecting the tablets to get high". Promising medications lend hope to addicts seeking treatment. 
Shelton, D., St. Louis Post-Dispatch, August 8, 2005.
http://www.montereyherald.com/mld/montereyherald/news/nation/12330302.htm
"…they liked the medication and tolerated it well; side effects were minimal and no serious adverse events occurred." Community Treatment Programs Take Up Buprenorphine.Science & Practice Perspectives, August 2004.
http://www.drugabuse.gov/PDF/Perspectives/vol2no2/03Perspectives-Community.pdf column 1, paragraph 5
Verthein, U., et al., Treatment of Opiate Addicts With Buprenorphine: A Prospective
Naturalistic Trial. Addictive Disorders and Their Treament, Volume 3(2), June 2004, pp 58-70.
Fiellin, D., et al, Office-Based Treatment for Opioid Dependence: Reaching New Patient Populations. The American Journal of Psychiatry, Volume 158(8), August 2001, pp 1200-1204.
Johnson, R. E., Cone, E. J., Henningfield, J. E., et al. (1989). A controlled trial of buprenorphine in the treatment of heroinaddiction. L. Physiological and behavioral effects during a rapid dose induction.Clinical Pharmacology and Therapeutics.1989:46:335-343.
Item 6 – Long lasting – up to 72 hours.
"Thetablet works within 30-60 minutes and lasts 24-48 hours, depending on the dose." South City Clinic http://www.southcityclinic.com.au/hp_bup.htm paragraph 2
Valmaña, A., Nonmethadone pharmacotherapies in opioid addiction, Current Opinion in Psychiatry, Volume 12(3), May 1999, pp 307-310.
Kosten, T., "Buprenorphine for Opioid Detoxification-A Brief Review" Addictive Disorders and Their Treatment, Vol 2(4) 2003, 107-112
"The half-life of buprenorphine in plasma is about 4–6 hours. Its duration of action, however, is much longer because of its exceptionally high affinity binding to mu receptors and a correspondingly slow dissociation." Bringing Buprenorphine- Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience/ Buprenorphine-Naloxone CTN Field Experience,The American Journal on Addictions, 13:S42–S66, 2004 http://www.aatod.org/conference_handouts/d2/d2.pdf
"Advantages Of Buprenorphine … Long duration of action" Buprenorphine: A New Office-based Treatment for Opioid Dependence, City Health Information, NYC Department of Health and Mental Hygiene, Vol 23 (4): 19-22. June 2004, page 19 http://www.nyc.gov/html/doh/downloads/pdf/chi/chi23-4.pdf
"Opiate substitution therapies and allow the addict to replace street heroin with a longer-acting, less euphoriant and safer drug whilst avoiding the withdrawal syndrome." New NICE work programme announced (June 2004), Methadone & Buprenorphine as opiate substitutes, National Institute of Clinical Excellence (UK) http://www.bivda.co.uk/news/index.cfm?ccs=115&cs=991 (paragraph 1)
"Both medications come in 2 mg and 8 mg strengths as sublingual (placed under the tongue to dissolve) tablets. The half-life of buprenorphine is 24–60 hours." http://drugabusehelp.com/drugs/buprenorphine/ Usage, paragraph 2.
"It still amazes him how quickly it worked. He didn"t feel high, didn"t feel withdrawal symptoms, didn"t even feel medicated; he just felt better. "It took away the pain," he says. "It even took away the craving. I had my strength back, and I was eating sooner than I ever had in detox. I got clarity when I took that first pill." The Bitter Pill. Wired, Copyright 2005 http://www.lightparty.com/Health/BitterPill.html (paragraph 2
"The tablet works within 30-60 minutes and lasts 24-48 hours, depending on the dose." http://www.southcityclinic.com.au/hp_bup.htm (paragraph 6
Cornelis J. de Wet et al., "The rise of buprenorphine prescribing in England: analysis of NHS regional data 2001–03." Addiction, Volume 100 (4) 2005, 495 - 499.
"Buprenorphine is a long-acting partial opioid agonist.". Buprenorphine: A New Office-based Treatment for Opioid Dependence, City Health Information, NYC Department of Health and Mental Hygiene, Vol 23 (4): 19-22. June 2004, page 19 http://www.nyc.gov/html/doh/downloads/pdf/chi/chi23-4.pdf page 1
"Advantages Of Buprenorphine: long duration of action" Buprenorphine: A New Office-based Treatment for Opioid Dependence, City Health Information, NYC Department of Health and Mental Hygiene, Vol 23 (4): 19-22. June 2004, page 19 http://www.nyc.gov/html/doh/downloads/pdf/chi/chi23-4.pdf
"The elimination profile is similar to that observed for the other routes, comprising two phases of elimination of immunoreactivity, with plasma half-lives of 3 to 5 hours and >24 hours." http://www.drugabuse.gov/pdf/monographs/121.pdf page 7, Sublingual/paragraph 1
Fiellin, D., et al, Office-Based Treatment for Opioid Dependence: Reaching New Patient Populations, The American Journal of Psychiatry, Volume 158(8), August 2001, pp 1200-1204.
"Doses are required only once a day, sometimes even less often, because buprenorphine"s effects are long lasting."Advantages of buprenorphine maintenance treatment. Drug Info Clearinghouse (Australian Drug Foundation)
http://druginfo.adf.org.au/article.asp?ContentID=buprenorphine#how paragraph 1
"The effects begin within 30–60 minutes of taking the dose and peak within 2–4 hours, lasting between 4 hours to three days, depending on the dosage."BUPRENORPHINE Things You Need to Know: How is Buprenorphine Taken?,Tennessee Association of Alcohol, Drug & Other Addiction Services http://www.taadas.org/factsheets/buprenorphine.htm (paragraph 1)
"Buprenorphine is said to be long-lasting with minimal side effects…"." From the Administrator: How Is Buprenorphine Treatment Working? SAMHSA News. Charles G. Curie, M.A., A.C.S.W. Administrator, MHSA,March/April 2004, Vol. 12, Number 2. http://alt.samhsa.gov/samhsa_news/VolumeXII_2/index3.htm (paragraph 2
Item 7 – Fast acting results – many people feel the effects within minutes of their first dose.
"The tablet works within 30-60 minutes…depending on the dose." http://www.southcityclinic.com.au/hp_bup.htm parargraph 6
Verthein, U., et al., "Treatment of Opiate Addicts With Buprenorphine: A Prospective Naturalistic Trial." Addictive Disorders and Their Treament, Volume 3(2), June 2004, pp 58-70.
"The effects begin within 30–60 minutes of taking the dose and peak within 2–4 hours, lasting between 4 hours to three days, depending on the dosage." BUPRENORPHINE Things You Need to Know. How is Buprenorphine Taken,Tennessee Association of Alcohol, Drug & other Addiction Services http://www.taadas.org/factsheets/buprenorphine.htm (paragraph 1)
"It still amazes him how quickly it worked. He didn’t feel high, didn’t feel withdrawal symptoms, didn’t even feel medicated; he just felt better. "It took away the pain," he says. "It even took away the craving. I had my strength back, and I was eating sooner than I ever had in detox. I got clarity when I took that first pill."…" The Bitter Pill From Wired, Copyright 2005 http://www.lightparty.com/Health/BitterPill.html (paragraph 2
"For some patients, the period for transition to buprenorphine may be as little as 4 to 6 hours…" Practical Considerations for the Clinical Use of Buprenorphine. Science & Practice Perspectives. August 2004, page 9, column 2 http://www.drugabuse.gov/PDF/Perspectives/vol2no2/02Perspectives-Practical.pdf (paragraph 3.
Item 8 – Prescribed in the privacy of a doctor’s office – no one needs to know except the doctor. Pick up medication weekly or monthly in a pharmacy not daily in a clinic.
"It allows physicians to treat patients for this disease in the same manner that other people are treated for such other chronic illnesses as diabetes or high blood pressure. Office-based buprenorphine increases the availability of therapy by offering patients greater flexibility in treatment scheduling and integration with the mainstream public for their health services." Office-Based Therapy for Opiate Addiction Successful. Medical News Today, September 6, 2003 h ttp://www.medicalnewstoday.com/medicalnews.php?newsid=4254 (paragraph 4
Lintzeris N, Bell J, Bammer G, Jolley D, Rushworth L. 2002. A randomized controlled trial of buprenorphine in the management of short-term ambulatory heroin withdrawal.Addiction. 97:1395-1404.
"Buprenorphine will allow patients to be treated for addictions in the same manner as they are treated for other chronic illnesses, such as diabetes or hypertension." NIDA Research and SAMHSA Physician Traiing Combine to Put Care for Opiate Dependence in Hands of Family Doctor. SAMHSA News Advisory, October 9, 2004 http://www.samhsa.gov/news/newsreleases/021009ma_bupe_wNIDA.htm paragraph 4.
"Buprenorphine’s suitability for office-based prescribing is based on its pharmacologic profile." Successful Trial Caps 25-Year Buprenorphine Development Effort. Arnold Mann, NIDA NOTES Contributing Writer, NIDA Research Findings – Volume 19, No. 3, September 2004. page 4, column 1 http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf (paragraph 2.
Chawarski, M., Fiellin, D. et al. The Practice of Office-Based Buprenorphine Treatment of Opioid Dependence: Is It Associated with New Patients Entering into Treatment?Drug and Alcohol Dependence, July 2005. 79(1): pp 113-116,
Kuehn, Bridget. Office Based Treatment for Opioid Addiction Achieving Goals, JAMA, August 17, 2005. 294 (7): 784-786.
Fiellin, David A.Office-Based Treatment for Opioid Dependence: Reaching New Patient Populations. American Journal of Psychiatry, August 2001. 158:1200-1204."The FDA action will permit physicians to prescribe buprenorphine as part of office-based practice, making it possible for patients dependent on heroin or prescription painkillers such as OxyContin to receive treatment in their doctors’ offices rather than requiring daily visits to a centralized methadone clinic." Buprenorphine Approval Expands Options for Addiction Treatment. NIDA Research Findings, November 2002. Volume 17, Number 4, page 13,column 1. http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf paragraph 3.
"With physicians now able to prescribe buprenorphine, an alternative to methadone, from their office, individuals addicted to heroin are finding it much easier to return to a non-drug-dependent life."Methadone Substitute Helps Individuals Change Lifestyles.The New Bedford Standard-Times. http://www.drug-rehabs.com/methadone-substitute-help.htm (paragraph 1.)
"…a new methadone substitute that is helping her stay clean of heroin without the torpor of methadone or the burden of a daily clinic schedule." "I go to my nephew’s baseball games. (Before), my brother didn’t want me sitting in the stands," she said. "My family can come to my house, and I don’t have to worry that my dope dealer’s coming at the same time." Methadone substitute offers new hope for addicts. Jeannette Barnes. The Standard-Times. June 16, 2004 http://www.southcoasttoday.com/daily/06-04/06-16-04/a01lo385.htm (paragraphs 2,3
"…buprenorphine is a pill that is dispensed through a prescription from a physician. This makes it easier on addicted individuals because they’re not burdened with having to go to a clinic daily to receive treatment." Methadone Substitute Helps Individuals Change Lifestyles. New Bedford Standard Times. June 17, 2004. http://www.jointogether.org/sa/action/dt/news/reader/0,2812,571757,00.html (paragraph 3.)
"Advantages Of Buprenorphine: Prescribed in a doctor’s office and filled at a pharmacy" Buprenorphine: A New Office-based Treatment for Opioid Dependence, City Health Information, NYC Department of Health and Mental Hygiene, Vol 23 (4): 19-22. June 2004, page 19 http://www.nyc.gov/html/doh/downloads/pdf/chi/chi23-4.pdf
Item 9 – Immediate Return to Work – no time lost to "adjusting" to the medication or stays in a rehabilitation facility.
"…generally report that buprenorphine makes them feel much better—they’re energetic, their heads are clear, they can function." Community Treatment Programs Take Up Buprenorphine. Science & Practice Perspectives. August 2004. Page 4, column 1. http://www.drugabuse.gov/PDF/Perspectives/vol2no2/03Perspectives-Community.pdf (paragraph 1)
"…noticed people on buprenorphine could do a higher level of work." Community Treatment Programs Take Up Buprenorphine. Science & Practice Perspectives. August 2004. Page 4, column 1. http://www.drugabuse.gov/PDF/Perspectives/vol2no2/03Perspectives-Community.pdf (paragraph 1)
"Patients say buprenorphine makes it possible to live normal lives, including holding down jobs, while receiving drug treatment."Law expands treatment of addicted patients, Scott Hensley, The Wall Street Journal, August 11, 2005. http://www.post-gazette.com/pg/05223/552394.stm,
"But for others, buprenorphine can end cravings for street drugs without producing a high, allowing addicts to hold jobs or simply save their lives."Greater access to treatment hailed.Peter DeMarco, TheBoston Globe, August 7, 2005. http://www.boston.com/news/local/massachusetts/articles/
2005/08/07/greater_access_to_treatment_hailed/
"While Suboxone and Subutex are also bound by regulations, they can be administered at your Doctors office. Detoxification from even large doses of opiates like oxycodone and heroin can now be accomplished safely in an Outpatient setting in a relatively short period of time. And the cost of Outpatient Detox is far less than an Inpatient Hospital Program. Outpatient Detox also allows you a much faster return to work or school."
http://www.suboxone-directory.com/ (paragraph 5.)
"According to Yale’s Lynn Sullivan, M.D., buprenorphine helps addicts "stabilize and organize their often very chaotic lives." She says that the drug can have dramatic effects on daily functioning…"Buprenorphine: a New tool in the arsenal, HRSA CARE ACTION. March 2004. http://hab.hrsa.gov/publications/march04/ (paragraph 6.)
"I’ve been on it about four weeks, and I feel like I’ve been let out of jail," said a sculptor from Provincetown, Mass., who said buprenorphine has enabled her to return to work and renew relationships with her family. "Can you imagine how much this is going to change the world? I think it can really revolutionize the detox field." Methadone Substitute Helps Individuals Change Lifestyles.New Bedford Standard Times. June 16, 2004. http://www.jointogether.org/sa/action/dt/news/reader/0,2812,571757,00.html (paragraph 2.)
"Medications such as buprenorphine, along with psychosocial supports, can help people addicted to opiates stop craving their drugs and re-establish productive and fulfilling lives in the community. Buprenorphine alone is not a silver bullet for opioid addiction, but it can open the door to recovery and provide the opportunity to regain lost lives." From the Administrator: How Is Buprenorphine Treatment Working?SAMHSA News. Charles G. Curie, M.A., A.C.S.W. Administrator, MHSA,March/April 2004, Vol. 12, Number 2.
http://alt.samhsa.gov/samhsa_news/VolumeXII_2/index3.htm (paragraph 7)
Kuehn, Bridget, Office Based Treatment for Opioid Addiction Achieving Goals, JAMA, 294 (7): 784-786, August 17, 2005
"Staying off heroin can provide the opportunity to experience more ‘life opportunities’, such as. greater personal happiness, more close and stable relationships with others, employment and more money to buy goods for personal enjoyment."Advantages of buprenorphine maintenance treatment.Drug Info Clearinghouse (Australian Drug Foundation) http://druginfo.adf.org.au/article.asp?ContentID=buprenorphine#how
Schottenfeld, R. et al.2000. Thrice-weekly versus daily buprenorphine maintenance. Biological Psychiatry 47(12):1072-1079.
"Staying off heroin can provide the opportunity to experience more ‘life opportunities’, such as. Greater personal happiness, more close and stable relationships with others…" BUPRENORPHINE Things You Need To Know.
Advantages of buprenorphine maintenance treatment. Tennessee Association of Alcohol, Drug & Other Addiction Services. http://www.taadas.org/factsheets/buprenorphine.htm (paragraph 1.)
Fiellin, David A et al. Office-Based Treatment for Opioid Dependence: Reaching New Patient Populations,American Journal of Psychiatry. August 2001. 158:1200-1204.
"Buprenorphine combined with naloxone, an opioid antagonist, will be prescribed (as Suboxone) for long-term maintenance therapy that will allow patients to resume and maintain normal, productive lives during treatment."Buprenorphine Approval Expands Options for Addiction Treatment,, NIDA Research Findings, Volume 17, Number 4. November 2002, page 14, column 2
http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf (paragraph 1.)
2
"Treating people for opioid addiction has been shown to be effective in helping them return to work and achieve productive lives." Buprenorphine: A New Treatment for Opioid Dependency http://www.nyc.gov/html/doh/html/basas/buprenorphine-fact.shtml (paragraph 1.)
Item 10 – anecdotal evidence indicates when diverted to the streets, it is still used for its indication, not to "get high". Not a desirable choice for the misuser.
"It produces less of a "high" than other opioids, such as codeine and morphine. For this reason, it is less susceptible to abuse and may be easier to stop taking." Suboxone/Subutex. Indications. http://drugabusehelp.com/drugs/buprenorphine/ (paragraph 1)
"Out-of treatment opioid users won’t seek Suboxone to inject, because that will make them sick…" ." Community Treatment Programs Take Up Buprenorphine. Science & Practice Perspectives. August 2004. Page 2, column 2. http://www.drugabuse.gov/PDF/Perspectives/vol2no2/03Perspectives-Community.pdf (paragraph 2)
Pantalon, M., Fiellin, D. et al., Counseling Requirements for Buprenorphine Maintenance in Primary Care: Lessons Learned From a Preliminary Study in a Methadone Maintenance Program, Addiction Disorders and Their Treatment. Volume 3(2), June 2004, pp 71-76.
"Suboxone contains an additional ingredient called naloxone to prevent abuse. Suboxone is indicated for the maintenance phase of treatment and is used in the majority of patients." Suboxone/Subutex. Usage. http://drugabusehelp.com/drugs/buprenorphine/Usage/ (paragraph 1)
"With Suboxone, naloxone is added to buprenorphine to decrease the likelihood of diversion and abuse of the combination product." Suboxone/Subutex. Dependency. http://drugabusehelp.com/drugs/buprenorphine/ (paragraph 1)
"…buprenorphine can end cravings for street drugs without producing a high, allowing addicts to hold jobs or simply save their lives." Greater access to treatment hailed.Peter DeMarco, TheBoston Globe, August 7, 2005. http://www.boston.com/news/local/massachusetts/articles/
2005/08/07/greater_access_to_treatment_hailed/
"Buprenorphine, a partial opioid agonist, reduces withdrawal symptoms and blocks the effects of subsequently administered opioids, suggesting it might help reduce illicit opioid use. Due to the presence of naloxone, Suboxone is very likely to produce severe withdrawal symptoms if misused intravenously." Suboxone/Subutex. http://drugabusehelp.com/drugs/buprenorphine/, (Paragraph 3)
"…the combination behaves like naloxone, and abstinence is precipitated. Thus, diversion in a population of dependent opiate users would be strongly discouraged." Buprenorphine: An Alternative Treatment for Opioid Dependence.NIDA Research Monograph Series 121. Page 9. http://www.drugabuse.gov/pdf/monographs/121.pdf (paragraph 3)
"This product contains the opioid antagonistnaloxone and is designed to decrease the potential for abuse by producing withdrawal symptoms if used …" Buprenorphine: A New Office-based Treatment for Opioid Dependence, City Health Information, NYC Department of Health and Mental Hygiene, Vol 23 (4): 19-22. June 2004, page 19 http://www.nyc.gov/html/doh/downloads/pdf/chi/chi23-4.pdf
"These properties will make buprenorphine combined with naxolone undesirable for diversion to illicit use…"Buprenorphine Update: Questions and Answers. Is buprenorphine (alone and in combination) a safe and effective treatment for drug addiction? http://www.nida.nih.gov/Bupupdate.html (paragraph 2.)
"Suboxone, which contains a combination of buprenorphine and naloxone, an opiate antagonist. Neither formulation appears to have a large potential for abuse relative to other opioids."A new treatment for addiction. Etienne Benson. APA Online. Vol. 34, No. 6. June 2003. http://www.apa.org/monitor/jun03/newtreat.html (paragraph 8.)
Fiellin, David A. et al., Office-Based Treatment for Opioid Dependence: Reaching NewPatient Populations, American Journal of Psychiatry, August 2001, 158:1200-1204"Using buprenorphine on its own is unlikely to result in an overdose." BUPRENORPHINE Things You Need To Know. Advantages of buprenorphine maintenance treatment. Tennessee Association of Alcohol, Drug & Other Addiction Services. http://www.taadas.org/factsheets/buprenorphine.htm/ (paragraph 1.)
"Buprenorphine is said to be long-lasting, with minimal side effects and a low potential for abuse."From the Administrator: How Is Buprenorphine Treatment Working?SAMHSA News. Charles G. Curie, M.A., A.C.S.W. Administrator, MHSA,March/April 2004, Vol. 12, Number 2. http://alt.samhsa.gov/samhsa_news/VolumeXII_2/index3.htm (paragraph 2.)
"Increasing the dose of buprenorphine does not enhance the drug effects, however, so the medication is unlikely to be abused."Buprenorphine Approval Expands Options for Addiction Treatment.NIDA Notes. Volume 17,Number 4 (November 2002),
http://www.drugabuse.gov/NIDA_notes/NNVol17N4/Buprenorphine.html (paragraph 5.)
"…that contains buprenorphine and the opioid antagonist naloxone in a 4:1 ratio is designed to discourage illicit diversion and intravenous use of buprenorphine." Buprenorphine for Opioid Detoxification - A Brief Review. Kosten, Thomas R. Addictive Disorders & Their Treatment, Volume 2, Number 4, December 2003
Item 11 – Required dosage does not increase with time (unlike with full agonist opioids). The lebvel of tolerence is limited by the partial agonist affect.
"Unlike other opioids, users of buprenorphine rarely develop a tolerance to the drug. Maintenance dosages can remain at the same moderate level indefinitely, and in many cases even lowered, without discomfort." http://www.nationmaster.com/encyclopedia/Buprenorphine (Effects/paragraph 1.)
"Due to buprenorphine’s unique chemistry, raising the dosage will not result in a stronger analgesic effect after a certain point (around 16–32mg), beyond which the drug will actually have a reduced analgesic effect. A minor constituent of opium, thebaine or paramorphine (C19H21NO3) is chemically similar to both morphine and codeine, but produces stimulatory rather than depressant effects. ...Opioid receptors are a group of G-protein coupled receptors with opioids as ligands. ..."Naloxone is a drug used to counter the effects of overdosing on opioids such as heroin and morphine. ... http://www.nationmaster.com/encyclopedia/Buprenorphine#Effects (Effects/paragraph 1.)
"The increasing effects of partial agonists reach maximum levels and do not increase further…"Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction.April 23, 2004/page 2/Partial Agonists, column 1.http://www.csam-asam.org/Bup%20Clinical%20Info/BupTIP40/BupChapter2.pdf
(paragraph 1.)
Sporer, Karl A. Buprenorphine: A Primer for Emergency Physicians. Annals of Emergency Medicine. May 2004. 43(5): 580-584.
"Clinicians can achieve the maintenance dose of buprenorphine by doubling the dose each day up to a maximum of 24 to 32 mg." Practical Considerations for the Clinical use of Buprenorphine.Science & Practice Perspectives. August 2004. Page 10, column 2. http://www.drugabuse.gov/PDF/Perspectives/vol2no2/02Perspectives-Practical.pdf (paragraph 2.)
"It has the same effect on mu opiod receptors in the brain as does heroin or other opiate drugs, but it has a lower maximum effect." Buprenorphine Approval Expands Options for Addiction Treatment.NIDA Notes. Vol. 17, No. 4. November 2002. http://www.drugabuse.gov/NIDA_notes/NNVol17N4/Buprenorphine.html (paragaraph 5.)
"…the increasing effects of partial agonists reach maximum levels and do not increase further." Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), Partial Agonists/page 12, column 1, paragraph 1.
"The stabilization phase has begun when a patient has discontinued or greatly reduced the use of his or her drug of abuse, no longer has cravings, and is experiencing few or no side effects. The buprenorphine dose may need to be adjusted during the stabilization phase. Because of the long half-life of buprenorphine it is sometimes possible to switch patients to alternate-day dosing once stabilization has been achieved." BUPRENORPHINE Things You Need to Know: How is Buprenorphine Taken?Phases of Treatment. Tennessee Association of Alcohol, Drug & Other Addiction Services http://www.taadas.org/factsheets/buprenorphine.htm (paragraph 2)
"Eventually a maximum effect is reached – no further effects are produced, even with administration of higher doses."Use of Buprenorphine in the Pharmacologic Management of Opioid Dependence A Curriculum for Physicians. January 2001, by Eric C. Strain, MD, Editor and Jeanne G. Trumble, MSW, Project Director. Development of the curriculum was supported by the: Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration US Department of Health and Human Services. http://www.buprenorphine.samhsa.gov/Buprenorphine_Curriculum.pdf (pages 3-9.)
"Buprenorphine is pharmacologically related to morphine and is a partial opioid agonist: It has the same effect on mu opiod receptors in the brain as does heroin or other opiate drugs, but it has a lower maximum effect."Buprenorphine Approval Expands Options for Addiction Treatment.NIDA Notes. Vol. 17, No. 4. November 2002. http://www.drugabuse.gov/NIDA_notes/NNVol17N4/Buprenorphine.html,
"16-mg dose of the sublingual buprenorphine-alone tablet was more effective than the 8-mg dose in blocking the reinforcing effects of heroin." Pharmacology of Buprenorphine-Overview/Affinity, Intrinsic Activity, and Dissociation, (page 15, column 1.) http://www.csam-asam.org/Bup%20Clinical%20Info/BupTIP40/BupChapter2.pdf
Marsch L.A et al. Buprenorphine treatment for opioid dependence: the relative efficacy of daily, twice and thrice weekly dosing.Drug and Alcohol Dependence. 2005. 77:195–204.
"Dr. Pichot presented a slide showing increased mu-opioid receptor binding potential on positron emission tomographic scans as buprenorphine dose was increased. At 16 mg, the receptors were completely saturated." Outpatient Buprenorphine Treatment for Opioid Addiction.John E. Franklin, MD, MSc, http://www.medscape.com/viewarticle/470712?rss (paragraph 6.)
"…the goal of buprenorphine treatment is to treat with the minimum dose of medication needed to address target signs,…" Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), Stabilization Phase/page 56, column 2, paragraph 1.
"All the buprenorphine doses were given under direct observation and were moved to a regular schedule of Monday (12 mg), Wednesday (12 mg), and Friday (20 mg)." Office-Based Treatment for Opioid Dependence: Reaching New Patient Populations.David A. Fiellin, M.D., Robert A. Rosenheck, M.D., and Thomas R. Kosten, M.D. http://www.suboxone.com/Suboxone/pdfs/SuboxonePI.pdf (paragraph 1)2.)
Item 12 – Has shown effectiveness in treating refractory depression and pain.
"Ten subjects with …major depression were treated with the opioid partial agonist buprenorphine in an open-label study." "… completed 4 to 6 weeks of treatment and as a group showed clinically striking improvement in both subjective and objective measures of depression." Bodkin JA et al. 1995. Buprenorphine treatment of refractory depression. McLean Hospital, Consolidated Department of Psychiatry, Harvard Medical School, Belmont, MA, J Clin Psychopharmacol Feb; 15(1):49-57 http://opioids.com/buprenorphine/buprefdep.html
The kappa antagonism of Buprenorphine also offers a new approach in the treatment of depressive disorders. Clinical studies have shown that the overproduction or under-removal of the endogenous kappa agonist dynorphin can have a direct causal relationship with various depressive disorders.Fudala, P.J., et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone.New England Journal of Medicine. 2003.349(10):949-958.
Gerra, G., Borella, F. et al. Buprenorphine versus methadone for opioid dependence: predictor variables for treatment outcome.Drug and Alcohol Dependence 75 (2004) 37–45.
Kabirullah L., et al. Buprenorphine-Induced Antinociception Is Mediated by µ-Opioid Receptors and Compromised by Concomitant Activation of Opioid Receptor-Like Receptors. The Journal of Neuroscience, November 12, 2003. 23(32):10331-10337. http://www.jneurosci.org/cgi/content/full/23/32/10331
"Buprenorphine is used as a pain reliever and to treat opiate addiction. It produces less of a "high" than other opioids, such as codeine and morphine." Suboxone/Subutex. http://drugabusehelp.com/drugs/buprenorphine/ (Indications/paragraph 1.)
"…and its analgesic effect is due to agonism of μ-opioid receptors." http://www.nationmaster.com/encyclopedia/Buprenorphine#Effects, (Effects/paragraph 1.)
"Buprenorphine has been available…It is a safe and effective analgesic." Use of Buprenorphine in the Pharmacologic Management of Opioid Dependence A Curriculum for Physicians. January 2001, by Eric C. Strain, MD, Editor and Jeanne G. Trumble, MSW, Project Director. Development of the curriculum was supported by the: Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration US Department of Health and Human Services. http://www.buprenorphine.samhsa.gov/Buprenorphine_Curriculum.pdf (pages 3-29.)
"By attaching to the kappa receptor and slowing its activity, buprenorphine may induce positive mood and feelings of wellbeing." Practical Considerations for the Clinical use of Buprenorphine. (Science & Practice Perspectives. August 2004. Page 10, column 2.) http://www.drugabuse.gov/PDF/Perspectives/vol2no2/02Perspectives-Practical.pdf (paragraph2.)
"Suboxone and Subutex offer a fast, pain-free, withdrawal from highly addictive drugs." Suboxone and and Subutex – Pain Free Withdrawal and Detox.Buprenorphine Treatment for Opiate Addiction. http://www.suboxone-directory.com/ (paragraph 6.)
"Buprenorphine-maintained patients with pain may experience pain relief due to buprenorphine…" Criteria for Non-formulary Use of Buprenorphine Sublingual Tablets.VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. June 2003. Page 3. http://www.vapbm.org/criteria/Buprenorphine.pdf (paragraph 1.)
"The first medicine is called buprenorphine…It is like painkiller like medicines such as morphine,…" (Patient Information Leaflet/What are SUBOXONE and SUBUTEX?, page 2, paragraph 3.) http://www.fda.gov/cder/foi/label/2002/20732lppi.pdf
"…buprenorphine can be used as an analgesic agent…" Buprenorphine: An Analgesic with an Expanding Role in the Treatment of Opioid Addiction. Susan E. Robinson. (CNS Drug Reviews. 2002. Vol. 8, No. 4, pp. 377–390.) www.nevapress.com/cnsdr/Abstracts/8/377a.pdf#search=
'buprenorphine%20opioid%20addiction%20treatment
"When used as an analgesic, Buprenorphine is usually given…and doses are relatively low (compared with the doses of opioid addiction)." Buprenorphine: A New Treatment Option for Opioid Addiction, U.S. Department of Health and Human Services, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, A Treatment Improvement Protocol (TIP 40), Pharmacology of Buprenorphine/page 14, column 2, paragraph 1.
Item 13 – Counselors report, Because cravings and withdrawal are gone, it allows the individual to focus on the underlying reasons for the addiction.
"Maintenance treatment holds the person stable while they readjust their lives." ." BUPRENORPHINE Things You Need to Know: How is Buprenorphine Taken?Advantages of buprenorphine maintenance treatment. Tennessee Association of Alcohol, Drug & Other Addiction Services http://www.taadas.org/factsheets/buprenorphine.htm/ (paragraph 1.)
"The immediate goal is the reduction of drug craving and the prevention of relapse to compulsive drug taking."Anticraving Medications for Relapse Prevention: A Possible New Class of Psychoactive Medications.American Journal of Psychiatry; August 14, 2005,162:1423-1431 http://www.rednova.com/news/health/207131/anticraving_medications_
for_relapse_prevention_a_possible_new_class_of/ (paragraph 3.)
"…in combination with psychotherapy or counseling, they can reduce the likelihood of relapse."
Anticraving Medications for Relapse Prevention: A Possible New Class of Psychoactive Medications.American Journal of Psychiatry; August 14, 2005,162:1423-1431 http://www.rednova.com/news/health/207131/anticraving_medications_
for_relapse_prevention_a_possible_new_class_of/ (paragraph 1.)
Lawental E., 2000. Ultra rapid opiate detoxification as compared to a 30-day inpatient detoxification program-a retrospective follow-up study. J Subst Abuse; 11:173-181.
McLellan AT, Lewis DC, et al. 2000. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation.JAMA; 284:1689-1695
"…refer patients to appropriate counseling and support services to enhance pharmacological treatment." Buprenorphine Approval Expands Options for Addiction Treatment.NIDA Notes. Vol. 17, No. 4. November 2002. Page 17, column 1. http://www.drugabuse.gov/NIDA_notes/NNVol17N4/Buprenorphine.html paragraph 2.(November 2002)
Schottenfeld, R.S.; Pakes, 2000. Thrice-weekly versus daily buprenorphine maintenance.Biological Psychiatry 47(12):1072-1079.
"Simply put, as a partial opioid agonist, buprenorphine reduces withdrawal symptoms and blocks the effects of subsequently administered opioids. Suboxone also exhibits a "ceiling effect" on respiratory depression, thereby decreasing the danger of overdose compared to other opioids." Suboxone/Subutex. http://drugabusehelp.com/drugs/buprenorphine/ (paragraph 3.)
"Patients need a specific psychosocial treatment plan to help them maintain drug abstinence after completion of withdrawal." Practical Considerations for the Clinical use of Buprenorphine.Science & Practice Perspectives. August 2004. Page 11, column 2. http://www.drugabuse.gov/PDF/Perspectives/vol2no2/02Perspectives-Practical.pdf (paragraph 2.)
"…it is strongly recommended that those wanting to remain free of heroin engage in a treatment program that addresses the physical (the body), psychological (the mind) and environmental issues relating to the person’s drug use. This may involve combining several treatment approaches, such as buprenorphine maintenance, counseling, alternative or holistic therapies such as massage and naturopathic treatment; and developing a positive support network including peers, family and friends and support groups." BUPRENORPHINE Things You Need to Know: How is Buprenorphine Taken?How effective is Buprenorphine. Tennessee Association of Alcohol, Drug & Other Addiction Services http://www.taadas.org/factsheets/buprenorphine.htm (paragraph 1.)
"Medications such as buprenorphine, along with psychosocial supports, can help people addicted to opiates stop craving their drugs and re-establish productive and fulfilling lives in the community. Buprenorphine alone is not a silver bullet for opioid addiction, but it can open the door to recovery and provide the opportunity to regain lost lives." From the Administrator: How Is Buprenorphine Treatment Working?SAMHSA News. Charles G. Curie, M.A., A.C.S.W. Administrator, MHSA,March/April 2004, Vol. 12, Number 2.http://alt.samhsa.gov/samhsa_news/VolumeXII_2/index3.htm (paragraph 7.)
"It still amazes him how quickly it worked. He didn't feel high, didn't feel withdrawal symptoms, didn't even feel medicated; he just felt better. "It took away the pain," he says. "It even took away the craving. I had my strength back, and I was eating sooner than I ever had in detox. I got clarity when I took that first pill."The Bitter Pill From Wired, Copyright 2005 http://www.lightparty.com/Health/BitterPill.html (paragraph 2.)
"During maintenance treatment, providers should assess the patient and provide treatment for other issues that the person is facing, to help get him/her stabilized and live a more fulfilled life." Buprenorphine Treatment: A Training for Multidisciplinary Addiction Professionals. Module III-Buprenorphine 101, slide 25. http://www.projectmainstream.net/newsfiles/1180/TrainerManuelBup
Awarenessfinal.htm#_Toc72743674
Kuehn, Bridget., Aug 17, 2005. Office Based Treatment for Opioid Addiction Achieving Goals, JAMA, 294 (7): 784-786
Item 14 – Addiction is less likely than any other opioids and Buprenorphine is easier to discontinue.
"Patients were able to terminate buprenoprhine treatment more comfortably than methadone treatment because of buprenorphine’s milder withdrawal effects." Practical Considerations for the Clinical use of Buprenorphine.Science & Practice Perspectives. August 2004. Page 4, column 1 http://www.drugabuse.gov/PDF/Perspectives/vol2no2/02Perspectives-Practical.pdf (paragraph 2.)
"…it produces less stimulation and physical dependence than full agonist medications,…" Opening the Door to Mainstream Medical Treatment of Drug Addiction.Glen R. Hanson, Ph.D., D.D.S., NIDA Acting Director, NIDA Research Findings, Column 2, paragraph 3 Volume 17, Number 5. January 2003. http://www.nida.nih.gov/PDF/NNCollections/NNHeroin.pdf
"…the withdrawal syndrome upon discontinuation of buprenorphine is, at worst, mild to moderate and often can be managed without administering narcotics." Advocacy News from ASAM: Buprenorphine Legislation Hailed as Treatment Breakthrough http://www.gilman.yourmd.com/ (patient resources.)
"Buprenorphine is considered to have less risk for causing psychological and or physical dependence than the drugs in Schedule II such as morphine, oxycodone, fentanyl, or methadone." Subutex and Suboxone Approved to Treat Opiate Depedence. FDA Talk Paper. October 8, 2002.
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01165.html (paragraph 4.)
"This medication is different from methadone in that it offers less risk of addiction and can be dispensed in the privacy of a doctor's office." http://www.oxycontin-help.com/web_linkdisplay.cfm?cat_id=168&link=Heroin%20Treatment/ (Treatment/paragraph 5.)
"…buprenorphine is much easier and better tolerated than the withdrawal experienced with opioid agonists. Although buprenorphine could be tapered in 3-4 days…"Outpatient Buprenorphine Treatment for Opioid Addiction. John E. Franklin, MD, MSc
http://www.medscape.com/viewarticle/470712?rss (paragraph 1.)
"However, degree of physical dependence is less than that produced by full agonist opioids. This means withdrawal syndrome should be less severe for buprenorphine."Use of Buprenorphine in the Pharmacologic Management of Opioid Dependence A Curriculum for Physicians. January 2001, by Eric C. Strain, MD, Editor and Jeanne G. Trumble, MSW, Project Director. Development of the curriculum was supported by the: Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration US Department of Health and Human Services.
http://www.buprenorphine.samhsa.gov/Buprenorphine_Curriculum.pdf (pages 3-44.)
"…Improvements in mental health." Use of Buprenorphine in the Pharmacologic Management of Opioid Dependence A Curriculum for Physicians. January 2001, by Eric C. Strain, MD, Editor and Jeanne G. Trumble, MSW, Project Director. Development of the curriculum was supported by the: Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration US Department of Health and Human Services. http://www.buprenorphine.samhsa.gov/Buprenorphine_Curriculum.pdf (pages 1-15.)
Kabirullah L., et al. Buprenorphine-Induced Antinociception Is Mediated by µ-Opioid Receptors and Compromised by Concomitant Activation of Opioid Receptor-Like Receptors.The Journal of Neuroscience. November 12, 2003. 23(32):10331-10337. http://www.jneurosci.org/cgi/content/full/23/32/10331
Schottenfeld, R.S., Pakes, J. et al. 2000. Thrice-weekly versus daily buprenorphine maintenance.Biological Psychiatry 47(12):1072-1079.
Item 15 – Doctors must take an 8-hour class to prescribe and are limited by law to only treating 30/100 patients at any one time.
The 2000 Drug Addiction Treatment Act allows qualified physicians who are certified in addiction medicine or addiction psychiatry, who have completed eight hours of authorized training, or who have participated in a clinical trial to office-base prescribe schedule III, IV, and V drugs approved for the treatment of opioid dependence. Currently, buprenorphine is the only drug that fits into this category.Buprenorphine for the Treatment of Opioid Dependence. University of Montana. Vol 4 No. 5 May 2003 School of Pharmacy and Allied Health Sciences Drug Information Services, page 1, http://www.spahs.umt.edu/DIS/pdf/buprenorphine.pdf (paragraph 1.)
"DATA 2000 permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid addiction with Schedule III, IV, and V opioid medications or combinations of such medications that have been specifically approved by the Food and Drug Administration (FDA) for that indication. Such medications may be prescribed and dispensed." Drug Addiction Treatment Act of 2000 (DATA 2000), SAMHSA http://buprenorphine.samhsa.gov/titlexxxv.html
"President Bush has signed into law an amendment to the Controlled Substances Act that will increase the availability of Buprenorphine (Suboxone®) for the treatment of opioid dependence/addiction. This amendment removes the 30-patient limit on group medical practices that treat opioid dependence with Buprenorphine. The restriction was part of the original Drug Addiction Treatment Act of 2000 (DATA) that allowed treatment of opioid dependence in a doctor's office. With this change, every certified doctor may now prescribe buprenorphine up to his or her individual physician limit of 30 patients. Today's action is a significant step forward in expanding treatment access to those who have the chronic disease of opioid dependence." Restrictions on Medical Groups that Prescribe Buprenorphine are Lifted, NAABT, Inc.http://naabt.org/30_patient_limit.cfm
" progress in training physicians--using curricula that have been shaped by psychologists – has been rapid." A new treatment for addiction. Etienne Benson. APA Online. Building a Network http://www.apa.org/monitor/jun03/newtreat.html (paragraph 2.)
"Completion of at least 8 hours of approved training in the treatment or management of patients dependent on opioids…" Practical Considerations for the Clinical use of Buprenorphine.Science & Practice Perspectives. August 2004. Page 8, column 2. http://www.drugabuse.gov/PDF/Perspectives/vol2no2/02Perspectives-Practical.pdf
- U.S. Food and Drug Administration, FDA Talk Paper, T0238, October 8, 2002, Subutex and Suboxone approved to treat opiate dependence.
- Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004.