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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
Glossary of Terms
A collection of opioid addiction and medication assisted treatment terms and their definitions.
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A
Excessive use of a substance in a way it was not meant to be used or not as prescribed.
Problem with the term: Although this is a clinical diagnosis in the DSMIV and ICD10, this is a stigmatizing word because
- it negates the fact that substance use disorders are a medical condition;
- it blames the illness solely on the individual with the illness, ignoring environmental and genetic factors, as well as the drugs’ abilities to change brain chemistry;
- it absolves those selling and promoting addictive substances of any wrong doing;
- it feeds into the stigma experienced not only by individuals with substance use disorders, by also by family members and the treatment/recovery field. See also substance abuse.
Preferred terminology: Misuse, harmful use, inappropriate use, hazardous use, problem use, risky use, substance use disorder
Slang for person with an addictive disorder. This stigmatizing term is demeaning because it labels a person by his/her illness. By making no distinction between the person and the disease, it denies the dignity and humanity of the individual. In addition, this label implies a permanency to the condition, leaving no room for a change in status. see The Words We Choose Matter
Some in the recovery community feel the need to use the term to remind the patient that they have a problem. There is no evidence that such intentional humiliation is beneficial or that it outweighs the potential damage and increased difficulty in building back one’s self esteem or overcoming stigma.
Preferred terminology: Person with alcohol/drug disease, person with a substance use disorder, person experiencing an alcohol/drug problem, Patient or Person receiving services (if referring to an individual receiving treatment )addiction survivor.
A behavioral syndrome characterized by the repeated, compulsive seeking or use of a substance despite adverse social, psychological, and/or physical consequences, and a need for an increased amount of the substance, as time goes on, to achieve the same effect. Addiction is often (but not always) accompanied by physical dependence, a withdrawal syndrome, and tolerance.
The American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine recognize the following definitions and recommend their use: see document
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.
The strength with which a drug binds to its receptor is termed its affinity. The degree to which a drug activates its receptors is termed its intrinsic activity. Affinity for a receptor and activation of the receptor are two different qualities of a drug. A drug can have high affinity for a receptor but not activate the receptor (e.g., an antagonist). Mu opioid agonists, partial agonists, and antagonists can vary in their affinity.
Drugs that activate receptors in the brain are termed agonists. Agonists bind to receptors and turn them on. They produce an effect in the organism. Full mu opioid agonists activate mu receptors. Increasing doses of full agonists produce increasing effects until a maximum effect is reached or the receptor is fully activated. Opioids with the greatest abuse potential are full agonists (e.g., morphine, heroin, methadone, oxycodone, hydromorphone).
Organic compounds produced by plants. These substances constitute the active ingredients of many drugs.
Located deep within the cerebral hemispheres. It is part of the limbic system and plays an important role in motivation and emotional behavior
Medication to treat pain.
A substance that tends to nullify the effect of another (e.g., a drug that binds to a receptor without eliciting a response).
Part of the neuron which sends signals to nearby neurons.
B
Behavioral couples therapy.
Family of depressants used therapeutically to produce sedation, induce sleep, relieve anxiety, muscle spasms, and to prevent seizures. (Xanax®,Valium®,Ativan®,and Restoril® are some examples of benzodiazepines.) Not to be used in combination with Buprenorphine, unless under a doctor's care. In high doses benzodiazepines can cause dangerous respiratory depression. This can have an adding effect when combined with other CNS depressants like alcohol or opioids, and can be fatal. Abrupt cessation of benzodiazepines can cause seizures.
see benzodiazepine
The ability of a drug to enter the body. Ex. Naloxone has poor bioavailability when taken sublingually.
Combining biological, psychological, and social concerns or effects.
Behavioral marital therapy. BMT combines a focus on addiction with efforts to strengthen the marital relationship through shared activities and the teaching of communication and conflict evaluation skills.
An invisible though often effective barrier within a relationship that governs the level of contact. Boundaries can appropriately shape and regulate relationships. Two dysfunctional types of boundaries are those that are (1) so rigid, inhibiting meaningful interaction so that the people in the relationship are said to be “disengaged” from each other, or (2) so loose that individuals lose a sense of independence so that the “enmeshed” relationship stifles individuality and initiative.
Part of the brain responsible for automatic survival behaviors.
BupeNx,bup/nx or BupNx are abbreviations for [buprenorphine hydrochloride and naloxone hydrochloride] combination medications. The brand name is Suboxone®. As generic competition enters the market "BupeNx" might become a more commonly used term as to differentiate from the branded product or refer to the family of drugs including the branded product and the generics. NOTE: BupeNX does NOT refer to Buprenex®, a brand name for injectable buprenorphine.
Buprenex® Buprenex PI (Generic: Buprenorphine hydrochloride) is a trade name for an injectable formulation of the Schedule III partial opioid agonist Buprenorphine. It was FDA approved for use as an analgesic in 1981, (originally patented in 1969). It is Not FDA approved for use in the treatment of opioid addiction. On October 7, 2002 the DEA changed the Scheduling of Buprenex® from a Schedule V to a Schedule III. See DEA rescheduling act
Physicians certified under DATA-2000 (or any other physicians in the US) are NOT authorized to prescribe Buprenex® for the treatment of opioid addiction. The only buprenorphine products that have been approved for the treatment of opioid dependence (addiction) are Suboxone® and Subutex®(and its generic equivalent).
A semi-synthetic opioid partial agonist that is a derivative of thebaine. Originally patented in March 18, 1969 (US Patent# 3,433,791), then FDA approved an injectable formulation called Buprenex® to treat pain in 1981.
Currently there are 3 sublingual formulations of Buprenorphine – the Schedule III pharmaceutical Subutex® (Buprenorphine), its generic equivalent, and Suboxone® (Buprenorphine/naloxone) – all received Food and Drug Administration (FDA) approval for use in the treatment of opioid addiction, and due to the law (DATA-2000) qualifying physicians are able to prescribe these medications for opioid dependence (addiction).
These 3 sublingual formulations (Suboxone®, Subutex®, and the Subutex generic)are only FDA approved buprenorphine medications for opioid dependence, and the only ones DATA-2000 authorizes certified physicians to prescribe for opioid dependence (addiction).
(Suboxone®) Suboxone PI There have been reports from several countries of misuse of buprenorphine by injection. Because of this buprenorphine misuse, a sublingual tablet form containing naloxone has been developed for the U.S. market to decrease the potential for misuse of the combination product via the injection route. Sublingual naloxone has relatively low bioavailability (Preston et al. 1990), while sublingual buprenorphine has good bioavailability. (Both naloxone and buprenorphine have poor GI bioavailability.) Thus, if a tablet containing buprenorphine plus naloxone is taken as directed—sublingually—the patient will experience a predominant buprenorphine effect. However, if an opioid-physically dependent individual dissolves and injects the combination tablet, then the antagonistic effect of naloxone predominates because of its high parenteral bioavailability (Stoller et al. 2001). Under such circumstances, the individual should experience a precipitated withdrawal syndrome. This should decrease the likelihood of misuse of the combination tablet by the injection route.
C
Cognitive–behavioral therapy. In (CBT), the therapist helps the patient learn new skills to cope with problems and to change harmful behavior patterns, such as substance abuse.
Because of the limited intrinsic activity of buprenorphine at the receptor and the finite amount of receptors, there is a limit as to the opioid effect one receives. The increasing effects of partial agonists reach maximum levels and do not increase further, even if doses continue to rise. With most patients this occurs at about 12-16mg of sublingual buprenorphine. As the dosage is increased beyond the ceiling no difference in euphoria, analgesia, or respiratory depression will be felt.
CNS. Consists of the brain and the spinal cord.
Brain's outer surface.
Either of the two equal halves of the cerebrum. Each hemisphere is connected to functions on the opposite side of the body.
The protective fluid of the brain and spinal cord.
Part of the brain which is divided into hemispheres. It controls and integrates motor, sensory, and higher mental functions, such as thought, reason, emotion, and memory.
Of a long duration: a chronic illness persists for weeks, months, or even for life.
Clinical Laboratory Improvement Amendments -- Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. Some government and judicial department must only use CLIA-waved tests.
Naturally occurring narcotic alkaloid found in opium. It is required to make hydrocodone.
A state of being overly concerned with the problems of another, to the detriment of one’s own wants and needs.
Term used when quitting drugs on one’s own with no medical help. Abruptly discontinuing drug use in an effort to quit long term. This is only successful in less than 5% of the people who quit opioids “cold turkey”. One of the symptoms of withdrawal is "goose flesh" (horripilation) and looks like a Cold turkey
The type of behavior a person exhibits that is overpowering, repeated, and often irrational.
Clinical Opiate Withdrawal Scale (COWS) is used to quantify severity of opioid withdrawal. Symptoms are rated, added up and the total is the COWS score. A score of 5-12 is Mild withdrawal, 13-24 = Moderate, 25-36 Moderate to Severe and More than 36 = Severe.
COWS sheet used prior to buprenorphine induction
Physiological need for a substance. Powerful desire for a substance that cannot be ignored. Unnaturally strong desire/urge for a substance. An overpowering urge that people are ill-equipped to control through will. Usually it cannot be suppressed indefinitely and results in taking the substance.
Craving (formerly called psychological dependence ) is an intense desire to reexperience the effects of a psychoactive substance. Craving is the cause of relapse after long periods of abstinence.(N Engl J Med 2003;349:975-86.)
Normal neurobiological event of tolerance to effects of medication within the same class(Ann Intern Med. 2006;144:127-134)
The Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA), within the U.S. Department of Health and Human Services (HHS), promotes the quality and availability of community-based substance abuse treatment services for individuals and families who need them
D
Drug Enforcement Administration.
www.dea.gov
Drug of Choice
DATA-2000 is a law that 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. This is the law that makes it legal for doctors to prescribe buprenorphine for opioid addiction treatment. It also limits certified doctors to only helping 30 patients at any one time for the first year of certification and up to 100 thereafter, regardless of the needs of the community. DATA-2000
Demerol® is a Brand name for meperidine HCl an analgesic available in tablet and syrup forms. Manufactured by Sanofi-Synthelabo Inc., it is prescribed for the relief of moderate to severe pain in many medical, surgical, obstetrical and dental situations. The syrup contains 50 mg of meperidine hydrochloride, per 5 ml teaspoon (25 drops contain 13 mg of meperidine hydrochloride). The tablets contain 50 mg or 100 mg of the analgesic.
The part of the neuron which receives signals. There can be hundreds on a single neuron.
A common reaction of people with substance use disorders who, when confronted with the existence of those disorders, deny that they have a substance abuse problem and/or have lost control of it. This is a complex reaction that is the product of psychological and physiological factors, especially those concerned with memory and the influence of euphoria produced by the substance of abuse. It is not a deliberate, willful act on the part of the person who is abusing substances but is rather a set of defenses and distortions in thinking caused by the use of substances.
“dependence” by itself has little meaning in the field of addiction treatment. This is because currently the phrase “substance dependence” and “physical dependence” have very different meanings. Which “dependence” is someone referring to when the word is used alone in this context? Confusing the two could lead to a misunderstanding at best and a misdiagnoses at worse. There is some talk within the industry to bring back the word “addiction” to use in place of “substance dependence” in an effort to help with some of the confusion. For the time being we are stuck with two similar phrases with two very different meanings. Understanding the difference is essential.
see: physical dependence, substance dependence, craving, and addiction
The metabolic process by which the toxic qualities of a poison or toxin are reduced by the body. Pertaining to addiction it is generally a medically supervised treatment for alcohol or drug addiction designed to purge the body of intoxicating or addictive substances. Such a program is used as a first step in overcoming physiological or psychological addiction.
The word “detoxification” or “detox” is not appropriate when speaking of a medical withdrawal from a treatment medication such as buprenorphine. The word incorrectly implies that buprenorphine is toxic. This contributes to the stigma and the false notion that treatment medications are simply switching one addiction for another, by equating a lifesaving treatment medication with a poison or dangerous drug. The terms “taper” or “medical withdrawal” are preferred.
Dilaudid® is a Brand name for Hydromorphone HCl - Antitussive available in tablet, suppositories, liquid and ampul forms. Manufactured by Knoll Pharmaceuticals, it is prescribed for the relief of moderate to severe pain. Ampuls: Each mL of sterile solution contains: hydromorphone HCI 2 mg. Oral Liquid: Each mL of clear, unflavored, syrupy liquid contains: hydromorphone HCI 1 mg. Suppositories: Each suppository contains: hydromorphone HCI 3 mg in a cocoa butter base with 1% colloidal silica. Tablets: Each tablet contains: hydromorphone HCI 1 mg (green), 2 mg (orange), 4 mg (yellow) or 8 mg (white).
a condition that results in medically significant symptoms in a human;
a disorder with recognizable signs and often having a known cause;
dis-ease, the opposite of ease, when something is wrong with a bodily function.
In the context of addiction, some people reject the fact that addiction is a disease, despite that top medical organizations proclaimed it true over 50 years ago. The word disease may imply to some that addiction can be treated with medication alone. Proper addiction treatment requires psychosocial care as well.
Dopamine is a chemical naturally produced in the body. In the brain, dopamine functions as a neurotransmitter which provides feelings of euphoria and well being. Endorphins are naturally occurring opioids that activate the dopamine pathway. All addictive substances activate the dopamine pathway. A person takes a drug of abuse, be it marijuana or cocaine or even alcohol, activating the same brain circuits as do behaviors linked to survival, such as eating, bonding and sex. The drug causes a surge in levels of dopamine, which results in feelings of pleasure. The brain remembers this pleasure and wants it repeated. If the brain senses that too much dopamine is being released it will adapt and inhibit dopamine release in an effort to normalize brain function. Once dopamine release is inhibited the external addictive substance is now required to maintain normal levels of dopamine.
Title XXXV of the Children's Health Act of 2000. The Drug Addiction Treatment Act of 2000 (DATA 2000)
establishes a waiver authority for qualifying physicians to prescribe or dispense specially approved Schedule III, IV, and V narcotic medications for the treatment of opioid addiction in clinical settings other than the Opioid Treatment Program setting. see 30/100 patient limit
The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), published by the American Psychiatric Association, is the handbook used most often in diagnosing mental disorders in the United States. The DSM has gone though five revisions (II, III, III-R, IV, IV-TR) since it was first published. The next version will be the DSM V, due in approximately 2011. The International Statistical Classification of Diseases and Related Health Problems (ICD) is a commonly-used alternative internationally.
Opposite of euphoria.
E
EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, Schedule II controlled substance. This is the first opioid medication indicated for pain containing a abuse resistant chemical safeguard. As with Suboxone®, the naloxone component of Embeda is intended to reduce misuse by injection and inhalation. Embeda contains pellets of an extended-release oral formulation of morphine sulfate, an opioid receptor agonist, surrounding an inner core of naltrexone hydrochloride, an opioid receptor antagonist indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Manufacturer: King Pharmaceuticals, Inc. Status: FDA Approved August 2009
As it applies to the disease of addiction, can be defined as doing for someone, in an attempt to help, those things they could or should be doing for themselves, thus actually making it easier for them to continue in the progression of the disease.
Opioids that are produced naturally in the body which have analgesic properties to make us better able to tolerate pain. They are endorphins, enkephalins, and dynorphins.
The name "endorphin", is derived from combining the words "endogenous morphine", which literally means "morphine produced naturally in the body". Endorphins are an opium-like substances produced naturally in the brain, which give a feeling of well-being and are natural painkillers. Production of endorphins is stimulated by many natural circumstances, including profound exercise.
The state of being in which two people are so close emotionally that one perceives the other as “smothering” him or her with affection, concern, attention, etc. Enmeshment also can occur without a conscious sense of it.
Psychological feeling of well being, extreme happiness.
Scientifically validated approaches are called evidence-based treatment. An array of healthcare initiatives to ensure that patients' medical care is grounded in the best scientific knowledge and is specifically appropriate for them. Evidence-based thinking is a process by which diverse sources of information are synthesized by a clinician, expert, or group of experts in order to identify or choose the optimal clinical approach for a given clinical situation.
An inert, inactive or clinically insignificant substance added to a drug usually as a carrier or as a binder of the active ingredient. Excipients may also help deliver the drug to the blood by helping with absorption or osmosis. Examples are corn starch, cellulose, talc, gelatin, polyethylene glycol, and lactose.
H
as in "drug habit". Outdated term for addiction or physical dependence. Calling substance use disorders a habit denies the medical nature of the condition and implies that resolution of the problem is simply a matter of willpower. Cigarette companies prefer this term instead of “addiction”. see The Words We Choose Matter
Hepatitus is inflammation of the liver. Hepatitis can be caused by infections with various organisms, including bacteria, viruses (Hepatitis A, B, C, etc.), or parasites. Chemical toxins such as alcohol, drugs, or poisonous mushrooms can also damage the liver and cause it to become inflamed. A rare but extremely dangerous cause of hepatitis results from overdose of acetaminophen (Tylenol), which can be deadly. In addition, immune cells in the body may attack the liver and cause autoimmune hepatitis. Hepatitis may resolve quickly (acute hepatitis), or cause long-term disease (chronic hepatitis). In some instances, progressive liver damage or liver failure may result.
Morphine diluted with acetyls. (diacetylmorphine) First introduced by The Bayer Company in Germany in 1895. Heroin is a full opioid agonist at the mu receptor.
Health Insurance Portability and Accountability Act
www.HIPAA.gov
I swear to fulfill, to the best of my ability and judgment, this covenant: I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow. I will apply, for the benefit of the sick, all measures which are required, avoiding those twin traps of over treatment and therapeutic nihilism. I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug. I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery. I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God. I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick. I will prevent disease whenever I can, for prevention is preferable to cure. I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm. If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.
Hydrocodone was developed as a cough medication. As it is an opiate, it is also an effective analgesic for mild to moderate pain control. Vicodin® (hydrocodone with acetaminophen) is a commonly misused hydrocodone medication. Vicodin, as with all narcotic analgesics, can lead to tolerance, physical dependence, addiction, and withdrawal symptoms if not taken as prescribed.
The part of the brain below the thalamus, forming the major portion of the ventral region of the diencephalon. It is the main control center for all organs and center of the limbic system.
I
Beginning phase and transition period when starting Buprenorphine treatment.
A neurotransmitter that induces electrical changes that make it difficult to generate a new nerve signal in the receiving neuron.
The property of a drug that determines the amount of biological effect produced per unit of drug-receptor complex formed. This is a measure of how much a particular drug “activates” a receptor. The lower the intrinsic activity, the lower the effect.
L
Emotional control center of the brain.
Neurotransmitter shape which allows only certain receptors interaction.
Lortab® is a Brand name for the combination of acetaminophen (Tylenol) and hydrocodone in tablet and liquid forms. Manufactured by UCB Pharma, Inc., it is prescribed for moderate to moderately severe pain. Liquid – 7.5 mg/500 mg per 15 mL; tablets – 2.5, 5.0, 7.5 or 10 mg. hydrocondone and 500 mg.
M
A stabilization period. The patient remains on the lowest effective dose for an indefinite amount of time. This allows the patient to prepare and make the necessary changes that would otherwise make long term abstinence unlikely.
A Schedule II synthetic full agonist opioid approved for use in the treatment of opioid addiction in Federally regulated opioid treatment programs.
Eye pupil constriction from either an increase in light or certain drugs or pathological conditions.
Therapy using one drug or approach.
Most active narcotic alkaloid of opium. Has powerful analgesic action; abuse leads to dependence.
Nerves which send commands from the brain to the body.
A drug that has affinity for and stimulates physiologic activity at mu opioid cell receptors. See also opioid full agonist.
A receptor on the surface membrane of nerve cells that mediates opioid analgesia, tolerance, and addiction through drug-induced activation. When an opioid agonist, or partial agonist (e.g., Buprenorphine), binds to a mu opioid receptor, a series of other proteins associated with the mu receptor-signaling pathway becomes activated. Other opioid receptors are the delta and kappa receptors.
N
Brand name: Narcan. An opioid antagonist, similar to naltrexone, that works by blocking opioid receptors in the brain, thereby blocking the effects of opioid agonists (e.g., heroin, morphine). Naloxone has poor bioavailability when taken sublingually. Naloxone has a high afinity to the mu opioid receptor, yet not as high of an affinity as buprenorphine, at the mu receptor.
A narcotic antagonist, works by blocking opioid receptors in the brain, without activating them, therefore, blocking the effects of opioids (e.g., heroin, morphine). Naltrexone has a High affinity to the Mu receptor, yet not as high as buprenorphine.
Narcotic Addict Treatment Act.
Blood clot caused by use of a needle. If dislodged, the clot may cause death.
When people repeat a behavior in order to avoid something unpleasant, such as use drugs to avoid withdrawal.
Nerve fibers and blood vessels wrapped in a fibrous sheath.
Axon of a single neuron.
a neurotransmitter that modulates the effects of other neurotransmitters.
A nerve cell. Neurons transmit information throughout the brain and body with electrical signals and chemical impulses.
Communication between neurons in the brain or between neurons and other cells in the body.
A molecule secreted by neurons for communicating nerve signal to other neurons, to muscles or to glands.
Drug or compound not related to natural or synthetic opium and related alkaloids. A drug that does not activate the opioid receptors.
Cluster of neuron cell bodies.
O
Office Based Opioid Treatment.
Once FDA approved, a drug product may be prescribed by a licensed physician for any use that, based on the physician’s professional opinion, is deemed to be appropriate. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label. Off-label use is not illegal, but means that the data to support that use have not been independently reviewed by the FDA. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, (usually as evidenced by peer-reviewed publications addressing the off-label use) and to maintain records of the product's use and effects.(1) The American Medical Association (AMA) has estimated that as many as 40% of all prescriptions are issued for off-label use.(2) It is common practice especially in pediatric and pregnant patients of whom pharmaceutical companies are reluctant to test on. Pharmaceutical companies cannot promote off-label uses of their drugs, and insurance companies may opt to withhold payment if a drug is being prescribed for a disorder that the medication was not indicated for. Malpractice insurance companies may not cover a physician for lawsuits resulting from off-label use of a drug.
There is an exception. Physicians are prohibited from prescribing opioid medications to treat opioid addiction unless the physician meets the special requirements outlined in DATA-2000, and then only specailly approved drugs can be used. For a relevant example, Buprenex® (injectable buprenorphine) is FDA approved for pain, but it is illegal for any doctor to prescribe it off-label for opioid addiction, even those doctors that hold a DATA-2000 waiver. The DEA clarifies this restriction in this document.
1.http://www.fda.gov/oc/ohrt/irbs/offlabel.html
2.American Academy of Pediatrics, Policy Statement 2002;110:1, July 2002:181-183.
2.American Academy of Pediatrics, Policy Statement 2002;110:1, July 2002:181-183.
A drug derived directly from the opium poppy plant. Synthetic and semi-synthetic drugs that resemble or act like an opiate are termed opioids. The entire family of both opioids and opiates are now commonly referred to as simply opioids.
Both drugs that are derived naturally from the opium poppy plant (e.g., morphine and opium) and that are synthetically produced in the lab (e.g., methadone and oxycodone)are collectively termed "opioids". Used therapeutically to treat pain, but also produce a sensation of euphoria – the narcotic "high." Chronic repeated misuse of opioids can lead to tolerance, physical dependence and addiction.
Subset of Substance dependence (DSM-IV) synonymous to and often used in place of “opioid addiction”; A chronic brain disease that involves a physical, psychological, and behavioral need for an opioid drug. This need is unrelated to medical necessity for pain relief. "Physical dependence" has a different meaning than "opioid dependence", the latter is "addiction" the former is the natural progression of tolerance to opioids.
Drugs that have affinity for and stimulate physiological activity at opioid cell receptors (mu, kappa, and delta) that are normally stimulated by naturally occurring opioids. Full agonists activate the receptor fully, as opposed to a partial agonist that will only provide limited effect. Repeated administration of full agonist exogenous opioids can lead to tolerance, physical dependence and addiction.
Drugs that can both activate and block opioid receptors, depending on the clinical situation. Partial agonists have properties of both agonists and antagonists. The mu agonist properties of partial agonists reach a maximum at a certain dose and do not continue to increase with increasing doses of the partial agonist. This is termed the ceiling effect. The ceiling effect limits the abuse potential and untoward side effects of opioid partial agonists. The Schedule III medication Buprenorphine is an opioid partial agonist. Opioid receptors are molecules on the surfaces of some nerve cells to which opioid compounds attach and through which they exert their effects. Different types of opioid receptors are present in the brain and other parts of the body. The receptor most relevant to opioid addiction and treatment is the mu receptor. It is through activation of the mu receptor that opioids exert their analgesic, euphorigenic, and addictive effects.
A neuroplastic change in pain perception resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the
analgesic effects of opioids.
(Ann Intern Med. 2006;144:127-134.)
Opium poppy plant. Thought to have been cultivated since before 3500 B.C. in Mesopotamia. Opium oozes from the center bulb of the flower when slightly cut or sliced.
Oxycodone is a medicine prescribed for moderate to high pain relief associated with injuries, bursitis, dislocation, fractures, neuralgia, arthritis, and lower back and cancer pain. It is also used postoperatively and for pain relief after childbirth. OxyContin®, Percocet®, Percodan®, and Tylox® are trade names of oxycodone-based products.
Brand name for high-strength, time-released oxycodone hydrochloride tablets. (picture) Manufactured by Perdue Pharma, (company info) it is prescribed for relief of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The tablets come in 10 mg, 20 mg, 40 mg, 80 mg, and 160 mg tablet strengths for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt.
P
Analgesic substances that relieve pain. Painkillers come in two classes opioid and non-opioid. The non-opioid analgesics come in over the counter and prescription forms, while opioid analgesics are only available through prescription and are potentially addictive.
Introduced by Perdue Pharma in the US market in January, 2005, brand name for hydromorphone hydrochloride in time-release capsule form. Manufactured by Perdue Pharma, it is prescribed in 12, 16, 24 and 32 mg. strengths. This drug is meant for people who have built up a tolerance to other opioids such as OxyContin. If someone were to take just one of the highest strength Palladone® capsules, and they did not have a tolerance to opioids, it could be enough for an overdose. Palladone was voluntarily taken off of the market in July of 2005 because a company study showed the time release mechanism could be bypassed if someone ingested alcohol with the medication, potentially leading to a fatal overdose.
Not through the gastrointestinal route; for instance, given via intramuscular or intravenous injection.
Partial agonists possess some of the properties of both antagonists and full agonists. Partial agonists bind to receptors and activate them, but not to the same degree as do full agonists. At lower doses and in individuals who are not dependent on opioids, full agonists and partial agonists produce effects that are indistinguishable. As doses are increased, both full and partial agonists produce increasing effects. At a certain point, however, the increasing effects of partial agonists reach maximum levels and do not increase further, even if doses continue to rise—the ceiling effect. This applies to any effect mediated by mu opioid receptors (e.g., analgesia, euphoria, respiratory depression). As higher doses are reached, partial agonists can act like antagonists—occupying receptors but not activating them (or only partially activating them), while at the same time displacing or blocking full agonists from receptors.
Withdrawal symptoms that continue after the initial acute withdrawal passes; The symptoms are less severe but can be long lasting. The symptoms are the result of long-term changes to the brain due to addiction. It is these withdrawal symptoms that drive many to relapse even months after drug use ends.
Structured relationship in which people meet in order to provide or exchange emotional support with others facing similar challenges. The group does not necessarily need to have healthcare providers among its members. Peer to peer groups are those such as AA, NA, smart recovery, and online line forums. Peer support by itself does not constitute treatment, but is one of the many tools that make up a treatment plan. Peer support should be used in conjunction with professional psychosocial therapy and/or medication as part of a comprehensive treatment plan.
Percocet®
Brand name for acetaminophen and oxycodone in tablet or capsule form. Manufactured by Endo Pharmaceuticals, it is prescribed for relief of moderate to moderately severe pain, including conditions accompanied by fever. Each capsule contains: Acetaminophen – 500 mg and Oxycodone HCl – 5 mg. Each tablet contains: Acetaminophen – 325 mg and Oxycodone – 5 mg.
Percodan® is a Brand name for oxycodone and asprin in tablet form. Manufactured by DuPont Pharma, Percodan is prescribed for the relief of mild to moderately severe pain, including conditions accompanied by fever and/or inflammation. Each tablet contains: Oxycodone Hydrochloride – 4.5 mg; Oxycodone Terephthalate – 0.38 mg; Aspirin, USP – 325 mg.
Parts of the nervous system outside of the Central Nervous System which form lines of communication between the CNS and the rest of the body.
Study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including correlation of these actions and effects with the chemical structure of the drug.
Study of the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion.
Treatment of disease by using medicines.
Normal physiologic state of adaptation to a substance, the absence of which produces symptoms and signs of withdrawal. It is possible to be physically dependent on a substance without being addicted to it.
(Ann Intern Med. 2006;144:127-134.)
The American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine recognize the following definitions and recommend their use. see document
Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
Biological study of the functions of living organisms and their parts.
Goose bumps, also called goose flesh, or the medical term cutis anserina, are the bumps on a person's skin at the base of body hairs which may involuntarily develop when a person is cold or experiences strong emotions such as fear or awe. The reflex of producing goose bumps is known as piloerection.
(pla-see'bo) A placebo is an inactive pill, liquid, powder, or other inert compound that has no treatment value. A substance or treatment that has no effect on human beings. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. The participants in the control group will receive a placebo instead of an active drug or treatment. Also referred to as a "sugar pill."
An apparently beneficial result of therapy that occurs because of the patient’s expectation that the therapy will help, not due to any medical treatment or substance. A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.
Concurrent use or abuse of multiple substances (e.g., drinking alcohol as well as smoking tobacco, snorting cocaine, inhaling glue fumes).
Neuron receiving a signal.
Patient Physician Matching System (PPMS) It is a way for DATA-2000 certified physicians, with treatment openings, to contact patients seeking buprenorphine treatment for opioid dependence. It is a centralized list of patients from which certified physicians, in your area, can draw from when they have an opening. It is a more efficient way to help connect patient to physician.
Patient Register/login - Physician Register/login
Patient Register/login - Physician Register/login
Precipitated withdrawal syndrome (PWS) can occur when an antagonist (or partial agonist, such as buprenorphine) is administered to a patient physically dependent on full agonist opioids, prior to the onset of initial withdrawal symptoms. Due to Buprenorphine’s high affinity and low intrinsic activity at the mu receptor, the partial antagonist displaces agonist opioids from the mu receptors, without activating the receptor to an equivalent degree, resulting in a net decrease in agonist effect, thus precipitating a withdrawal syndrome.
Neuron sending a signal.
Probuphine® is an innovative, long-term, implantable formulation of buprenorphine that is designed to provide a constant, low level of drug for six months following a single treatment. A depot formulation of buprenorphine presents intriguing prospects for populations such as prisoners, patients unable to comply with a daily dosing schedule, or to prevent diversion. Manufacturer: Titan pharmaceuticals Status: Not yet FDA approved, currently in phase 3 studies. US patent issues all but killed the drug in 2008, but in a October 2009 press release the National Institute on Drug Abuse (NIDA) awarded Titan a $7.6 million grant to complete phase 3 studies, suggesting that a workaround for the patent exists, such as orphan drug status perhaps. Studies are scheduled to resume 1st quarter of 2010.
Behavioral changes in patients that seem similar to those in patients with opioid dependence or addiction but are secondary to inadequate pain control.
(Ann Intern Med. 2006;144:127-134.)
Adequate pain relief continue to report persistent severe pain to prevent reduction in current opioid analgesic dose.
(Ann Intern Med. 2006;144:127-134.)
Mind-altering substance.
A compulsion to use a drug for its pleasurable effects. Such dependence may lead to a compulsion to misuse a drug. A craving and compulsion to use a drug that is psychologically rather than physiologically based, eg, compulsive gambling is a purely psychological dependence. Psychological dependence is sometimes called "chronic craving syndrom".
Combining psychological and social aspects.
R
Also called UROD (Ultra-rapid-opioid-detox) is an expensive procedure carried out in an ICU and the patient requires hospitalization. The patient is injected with very high doses of an opiate antagonist (naloxone) under general anesthesia or heavy sedation followed by a slow infusion of naloxone. Proponents of the procedure claim that complete accelerated detoxification is attained, the patient experiences no withdrawal symptoms, physical dependency is eliminated, and the psychological craving for drugs is greatly reduced. However, medical experts disagree. Some have called it malpractice and a fraud. In a comprehensive study published in the prestigious Journal of the American Medical Association (JAMA) in 2005 the scientists concluded, "Anesthesia-assisted detoxification should have no significant role in the treatment of opioid dependence"
(read the study here).
A neuron to which a molecule can bind activating the receptor and eliciting a response in the cell.
Depression that has not responded to other treatments.
When people repeat a behavior in order to experience something pleasant.
A relapse occurs when a person is affected again by a condition that affected them in the past. This could be a medical condition such as depression, bipolar disorder, cancer or an addiction to a drug. A recurrence of symptoms after a period of remission.
A period of time in which the signs and symptoms of the addiction have disappeared.
Time release, oxycodone based gel cap.It is an oxycondone medication indicated for pain like OxyContin®, but unlike OxyContin it will be difficult to misuse due to the suspension of the drug in a proprietary gel formulation that will make it difficult for misusers to bypass the time release mechanism. Manufacturer: King pharmaceuticals in partnership with Pain Therapeutics Inc Status: This drug has not yet received FDA approval, Phase III clinical trials are completed and the company plans to resubmit it to the FDA in the first 1/2 of 2010.
Opiate Replacement Therapy (ORT) is the medical procedure of replacing an addictive full agonist opiate such as heroin with a longer acting but less euphoric full agonist opiate such as methadone. Some argue buprenorphione treatment is not replacement therapy, because “replacement therapy” implies an equality to street drugs like heroin and treatment medications like buprenorphine. The term suggests a lateral move from illegal addiction to legal addiction and this does not accurately characterize the true nature of the treatment. The essence of addiction is uncontrollable compulsive behavior. The first goal of addiction treatment is to stop this dangerous addictive behavior. With successful buprenorphine therapy, as part of a comprehensive treatment plan, the dangerous addictive behavior is stopped not replaced.
the slowing or cessation of one's breathing which is sometimes associated with the use of opioids. This is the actual cuase of death in an opioid overdose.
S
Substance Abuse and Mental Health Services Administration – A division of the US Health Department. They have a special section for buprenorphine SAMHSA.gov
The act of helping or improving yourself without relying on anyone else.
"It is common to refer to Alcoholics Anonymous, Narcotics Anonymous, and other such organizations as self-help groups. Ernest Kurtz and William Miller have quite insightfully noted that such designation conveys a pulling-oneself-up-by-the-bootstraps image of addiction recovery. They noted, in contrast to this image, that people who seek help from such groups usually do so as an acknowledgment that all attempts at self-help have failed. Recovery in many support groups is not self-help but the utilization of resources and relationships beyond the self."
Excerpt from "The Rhetoric of Recovery Advocacy: An Essay On the Power of Language" by William White
Part artificial, part natural.
Short- acting Opioids have a half life of approximately 8 hours or less. (Examples: Heroin, Crushed OxyContin®, Percocet®, Vicodin®, Oxycodone®)
Brand name for Butorphanol Tartrate Analgesic available in spray form. Manufactured by Bristol-Myers Squibb, it is prescribed for the relief of moderate to severe acute pain. Each mL of aqueous solution contains: butorphanol tartrate 10 mg.
Under the tongue. Some medications are meant to bypass the harsh environment of the stomach and digestive system and enter the blood directly by absorption through the membranes beneath the tongue and into the blood vessels.
FDA approved in October 2002, Subutex and Suboxone are medications for the treatment of opiate dependence (addiction) Both medicines contain the active ingredient, buprenorphine hydrochloride, which works to reduce the symptoms of opiate dependence. Subutex contains only buprenorphine hydrochloride. This formulation was developed as the initial product. The second medication, Suboxone contains an additional ingredient called naloxone to guard against misuse. If Suboxone is crushed, dissolved and injected the otherwise inert naloxone component will initiate withdrawal, in opioid physically dependent people. When taken as directed the naloxone is clinically insignificant due to its low bioavailibilty through the sublingual route.
picture of tablets
Subutex and Suboxone are the first narcotic drugs available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate dependence (addiction) that can be prescribed in a doctor’s office. (source: FDA)
Substance Abuse is defined as a maladaptive pattern of substance use leading to clinically significant impairment or distress as manifested by one (or more) of the following, occurring within a 12-month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
- Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
- Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
With SUBSTANCE ABUSE the user has a choice: he/she uses in spite of illegal, unsafe consequences, or inappropriateness of the drinking/drugging experience. Opioid Abuse is a specific type of Substance Abuse.
The use of buprenorphine has been approved for the diagnosis of Opioid Dependence NOT Opioid Abuse. An accurate diagnosis is essential in determining what treatment if any is appropriate.
The American Psychiatric Association uses the term “substance dependence” in place of “addiction” however the two terms are synonymous, or more precisely “substance dependence” = “substance addiction” (since gambling addiction is not substance dependence) and is defined as a maladaptive
pattern of substance use leading to clinically significant impairment or distress.
To meet the criteria of Substance Dependence (addiction) as defined in the DSM-IV, a patient must meet 3 or more of the following occurring any time in the same 12-month period:
- Tolerance, as defined by either of the following:
(a) A need for markedly increased amounts of the substance to achieve intoxication or the desired effect
or
(b) Markedly diminished effect with continued use of the same amount of the substance. - Withdrawal, as manifested by either of the following:
(a) The characteristic withdrawal syndrome for the substance
or
(b) The same (or closely related) substance is taken to relieve or avoid withdrawal symptoms. - The substance is often taken in larger amounts or over a longer period than intended.
- There is a persistent desire or unsuccessful efforts to cut down or control substance use.
- A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects.
- Important social, occupational, or recreational activities are given up or reduced because of substance use.
- The substance use is continued despite knowledge of having a persistent physical or psychological problem
that is likely to have been caused or exacerbated by the substance (for example, current cocaine use
despite recognition of cocaine-induced depression or continued drinking despite recognition that an ulcer
was made worse by alcohol consumption).
Due to the resulting confusion between the terms "physical dependence" and "substance dependence" there is some talk within the industry of reintroducing the term "addiction" because it is better understood and may pose less chance of confusion.
See Suboxone®
Made from artificial materials – not natural occurring. With drugs: made in a lab rather than derived from a plant.
T
Fine grained mineral that is a silicate of magnesium, sometimes with small amounts of aluminum silicate. It has a soft, platy crystal structure. Talc is used in the manufacturing of cosmetics and pharmaceuticals. The inhalation of talc can lead to a chronic lung disease called talcosis which is related to silicosis. Talcum powder often used to contain traces of asbestos (because talc and asbestos form under similar circumstances and are commonly found together in the earth).
Formation of granulomas (small nodules) as a chronic inflammatory response, in the lungs or other organs, in this case to talc or other fine powder. Talc granulomatosis may occur in drug users because many injected drugs have been adulterated with an inert substance (such as talcum powder) to cut or dilute the amount of drug.
Is not available in the US. It is an international formulation of buprenorphine hydrochloride. It is also available as Temgesic-NX which contains Naloxone and buprenorphine (like Suboxone® in the US). It is meant as an analgesic. Temgesic is available outside the US in sublingual (.2mgs and .4mgs doses) and injectable formulations (.3mgs. and .6mgs. doses) These doses are considered too low to treat opioid addiction but are effective for mild to moderate pain.
A minor constituent of opium, thebaine is chemically similar to both morphine and codeine, but produces stimulatory rather than depressant effects. Used to manufacture Buprenorphine, Naltrexone, Naloxone, oxycodone.
Patients with adequate pain relief may demonstrate drug-seeking behaviors because they fear not only the reemergence of pain
but perhaps also the emergence of withdrawal symptoms.
(Ann Intern Med. 2006;144:127-134)
The progressive stepwise increase (or decrease) in drug dose to determine the optimal dose. To gradually increase (or decrease) the amount of a drug.
Normal neurobiological event characterized by the need to increase the dose over time to obtain the original effect.
A state in which a drug produces a diminishing biological or behavioral response; in other words, higher doses are needed to produce the same effect experienced initially.
The American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine recognize the following definition (see document):
Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.
A person, place, thing or event that can result in psychological and then physical relapse.
5mg. oxycodone, 500mg. acetaminophen (Tylenol).
U
Psychological desire for a substance. Urges can usually be suppressed by will. Urges are less powerful than cravings. Urges are often passing and temporary. Cognitive skills can be learned to effectively suppress urges.
Ultra Rapid Opioid Detox (see Rapid Detox)
As in "drug user". Outdated term describing a person who misuses drugs or alcohol, but not necessarily addicted. The term offers no distinction from chronic addictive behavior or use consistent with medical protocol. A person addicted to heroin and a patient taking pain medicine are both “users.” The term is stigmatizing because it labels a person by his/her behavior. It is also misleading because the term user has come to refer to one who is engaged in risky use of substances, but use alone (e.g. of alcohol or prescription medication) is not necessarily problematic. see The Words We Choose Matter
V
Vicodin® is a Brand name for acetaminophen (Tylenol) and hydrocodone in pill form. Manufactured by Watson Pharmaceuticals, Inc., Vicodin is prescribed for the relief of moderate to moderately severe pain. The usual adult Vicodin dosages: 500 mg/5 mg tablet – one or two tablets every four to six hours as needed for pain. The total 24 hour dose should not exceed 8 tablets; 650 mg/7.5 mg tablet – one tablet every four to six hours as needed for pain. The total 24 hour dose should not exceed 5 tablets.
W
Withdrawal syndrome consists of a predictable group of signs and symptoms resulting from abrupt removal of, or a rapid decrease in, the regular dosage of a psychoactive substance. The syndrome is often characterized by over activity of the physiological functions that were suppressed by the drug and/or depression of the functions that were stimulated by the drug.
Withdrawal from opioids is severe and excruciating. Withdrawal generally begins between 4 to 72 hours after the last opioid use (depending on the extent of use), The symptoms are both physical and emotional and include: dilated pupils, goose bumps, watery eyes, runny nose, yawning, loss of appetite, tremors, panic, chills, nausea, dry heaves, muscle cramps, insomnia, stomach cramps, diarrhea, vomiting, shaking, chills or profuse sweating, irritability, jitters, and increased sensitivity to pain.
X
Xanax® (generic name: alprazolam) is an anxiolytic benzodiazepine used to treat anxiety disorders, therefore, it provides a calming effect for the prescribed. Side effects range from drowsiness, fatigue, headache and clumsiness to the more severe blurred speech and vision and change in behavior. It is habituating, users build up a tolerance, and physical and psychological dependence is common. Caution should be used in using it in combination with Buprenorphine, or any other CNS depressant.
- 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.