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Pharmacotherapy Treatment of Alcoholism and Drug Addiction: Overview and Bibliography

Allison C. Colker, Esq.

December 31, 2004

Introduction

This issue brief provides a brief overview of various pharmacotherapy treatments for alcoholism and drug addiction, allowing the reader to gain a general knowledge of this ever-increasing treatment modality.  It is followed by a detailed bibliography organized by type of pharmacotherapy and type of addiction to provide the reader an opportunity to grain further information on research.  For further information, such as the pros and cons of pharmacotherapy treatment, please refer to the publications listed in the bibliography.  State legislators play a significant role in enhancing or capping pharmacotherapy treatment of alcoholism and drug addiction as both a purchaser and a provider of services.  State legislators must decide whether pharmacotherapy treatment is to be eligible for Medicaid reimbursement and at what rate, and whether state-funded clinics will provide pharmacotherapy treatment.

Overview

Prescribing medication to treat drug addiction began in the 1960s with methadone maintenance treatment, a program in which addicts visit clinics daily to receive single doses of methadone, an agonist medication.  The treatment originally was developed as part of a treatment program that also emphasized resocialization and job training (1).  There are two types of pharmacotherapy drugs, agonists and antagonists.  Agonists are chemicals that bind to and stimulate opiate receptors.  Antagonists block the effects of opiates by binding to receptors without stimulating them.  Mu agonists stimulate mu opiate receptors in the brain to produce the effects associated with morphine:  analgesia, euphoria, sedation and respiratory depression.  Naltrexone is an antagonist medication that is used to treat opiate addicts and alcoholics.  Buprenorphine is a partial mu agonist that will be used to treat heroin addicts, which was approved by the Food and Drug Administration (FDA) on October 8, 2002.

Methadone

Initially a hospital-based program, the acceptance and ability to control agonist maintenance treatment for opiate addicts has allowed outpatient treatment.  These programs use methadone, which are long-acting synthetic opiate medications.  They are administered orally for a sustained period at a dosage sufficient to prevent opiate withdrawal, block illicit opiate use effects and decrease opiate craving.  Patients function normally when stabilized on adequate, sustained dosages of methadone.  They are able to retain employment, avoid committing crimes and acts of violence, and reduce HIV exposure by stopping or decreasing injection drug use and drug-related high-risk sexual activity (2).

Methadone, a synthetic agent, occupies the brain receptor sites affected by opiates, such as heroin.  Methadone blocks opiates' euphoric and sedating effects; relieves opiate cravings, which cause relapse; relieves opiate withdrawal symptoms; does not cause euphoria or intoxication itself, so a person can work and participate in society; and is excreted slowly so it can be taken only once a day (3).

The standard methadone dose of 60 milligrams to 120 milligrams per day produces the optimum therapeutic effect, leading patients to stay in treatment longer, use less drugs, and have lower incidence of HIV infection.  However, some patients may require doses in excess of 120 milligrams per day for effective treatment (4).

Studies on the effectiveness of methadone treatment show that higher doses are more effective in reducing heroin use, helping patients stay in treatment, and reducing criminal activity.  There is evidence that doses must be determined on an individual basis (5) (as is done with any medication, e.g., allergy, heart or diabetes medicine).

Studies show that greater success rates in the treatment of substance abuse can be achieved, but depend on an adequate length of time in treatment for the individual.  Although 12 months of treatment is the recommended minimum, most patients leave before the full 12-month treatment is completed.  Often, patients discontinue treatment or they are discharged for noncompliance with program regulations.  Most of these patients will relapse to opiate use.  Clinical studies demonstrate that, like other chronic diseases, individuals may need multiple treatment episodes over time (6).  During the time they were in treatment, however, their criminal activity was decreased markedly.

It is common for patients to continue using drugs and alcohol after admission to methadone treatment because of a long history of use, complex situations and reasons for using drugs, and addiction's biological basis.  Many patients in treatment cannot control their addictions at all times.  Realistic expectations of treatment are that recovery is a day-to-day process with occasional relapses (7).

Clinical studies have demonstrated that patients who are stabilized on methadone can engage more readily in counseling and other behavioral interventions that are part of recovery and rehabilitation.  The most effective opiate agonist maintenance programs include individual and/or group counseling and provide, or refer patients to, other needed medical, psychological and social services (8).

Naltrexone

Naltrexone is an opiate antagonist that reduces the euphoric effect of opiates and alcohol.  It was approved by the FDA in 1984 for the treatment of opiate addiction (9).

Narcotic antagonist treatment using naltrexone for opiate addicts usually is done on an outpatient basis, but initiation of the naltrexone often begins after medical detoxification in a residential setting.  Naltrexone is a long-acting synthetic opiate antagonist with few side effects that is taken orally either daily or three times a week for a sustained period of time.  Patients must be medically detoxified and opiate-free for several days before they can take naltrexone; otherwise, it may precipitate an opiate abstinence syndrome.  When naltrexone is used this way, it completely blocks all the effects of self-administered opiates, including euphoria.  This treatment is based on the theory that the repeated lack of the desired opiate effects and the perceived futility of opiate use will gradually break the habit of opiate addiction.  Naltrexone has no subjective effects or potential for abuse and is not addictive.  Patient noncompliance is a common problem; therefore, a positive therapeutic relationship, effective counseling or therapy, and careful monitoring of medication compliance are necessary for a favorable treatment outcome (10).

Many clinicians have found naltrexone useful for highly motivated, recently detoxified patients--such as impaired professionals, parolees, probationers and prisoners on work-release--whose external circumstances demand total abstinence.  Patients can function normally when stabilized on naltrexone.  They can retain employment, avoid crime and violence, and reduce HIV exposure by stopping or decreasing injection drug use and drug-related high-risk sexual activity (11).

In 1994, Naltrexone also was approved for the treatment of alcoholism.  It was the first drug for alcoholism to be FDA-approved drug in 50 years.  It reduces the desire to drink and the craving for alcohol.  If a person on naltrexone consumes alcohol, the amount of consumption should be reduced (12).

Researchers have found that a combination of naltrexone and coping-skills training helps to reduce the chances of relapse among alcoholics.  Research participants who were given naltrexone had fewer relapses, took fewer drinks if they did relapse and had less of an urge to drink than those who received the placebo.  Furthermore, patients who received coping-skills training had fewer relapses than those who did not.  Since the research showed that the benefits of naltrexone did not continue after the medication was discontinued, researchers recommend that patients remain on the drug for a longer time period (13).

Buprenorphine

Buprenorphine is a partial opiate agonist that was approved by the FDA on Oct. 8, 2002, for the treatment of heroin addiction.  It is derived from thebaine, which is a constituent of opium.  Buprenorphine currently is marketed in the United States as an intractable pain medication under the name Buprenex.  The FDA approved two applications for buprenorphine as a treatment for narcotic addiction in a tablet form on Oct. 8, 2002.  A recent federal law will allow qualified physicians to dispense buprenorphine from their offices (14).

Buprenorphine significantly reduces patients' craving for heroin.  Buprenorphine, an analgesic, would join methadone, naltrexone and LAAM as the fourth medication available to treat opiate addiction.  Buprenorphine is an attractive and clinically helpful treatment option because of its unique effects and pharmacology.  When compared with other opiates such as morphine and heroin, buprenorphine produces less euphoria and causes a significantly lower degree of sedation and respiratory depression, the slowing down of breathing that makes heroin overdoses so dangerous.  Even high doses of buprenorphine--as much as 100 times the analgesic dose--do not produce dangerous respiratory effects (15).

Buprenorphine has limited side effects because it is a partial mu agonist.  Buprenorphine also readily binds to mu opiate receptors because it is a partial mu agonist; however, buprenorphine activates these receptors to a lesser degree than do full mu receptor agonists such as morphine and heroin (16).

Buprenorphine produces a long-lasting effect because it is released slowly from the mu receptor; therefore, it may be possible to give patients buprenorphine every other day, rather than daily as with methadone.  Some studies suggest that withdrawal effects are less severe with buprenorphine than with methadone.  Research has shown that buprenorphine can perform as favorably as methadone.  However, approval of buprenorphine would not diminish the importance of methadone in the treatment of heroin addiction (17).

Buprenorphine has some potential for misuse because it is a partial mu agonist.  Therefore, buprenorphine is subject to diversion--being sold by patients to other addicts.  This makes it unsuitable for use as a take-home medication.  Suboxone, a buprenorphine-naloxone combination tablet is designed to address this problem.  If a heroin addict dissolved the combination tablet and injected it intravenously, he would experience unpleasant withdrawal symptoms brought on by the naloxone component.  However, naloxone, an opiate antagonist, does not produce these effects when the combination tablet is taken sublingually, beneath the tongue (18).  The combination tablet was approved by the FDA on Oct. 8, 2002.

Notes

  1. "Methadone Maintenance Treatment."  Centers for Disease Control, (Feb. 2002).  (Apr. 1, 2002), <http://www.cdc.gov/idu/facts/MethadoneFin.pdf>.
  2. "Agonist Maintenance Treatment."  National Institute on Drug Abuse, National Institutes of Health, (Jan. 22, 2001).  (Apr. 1, 2002), http://165.112.78.61/PODAT/PODAT8.html.
  3. "Methadone Maintenance Treatment."   Centers for Disease Control, (Feb. 2002).  (Apr. 1, 2002), http://www.cdc.gov/idu/facts/MethadoneFin.pdf.
  4. Ibid.
  5. Ibid.
  6. Ibid.
  7. Ibid.
  8. "Agonist Maintenance Treatment."  National Institute on Drug Abuse, National Institutes of Health, (Jan. 22, 2001).  (Apr. 1, 2002), http://165.112.78.61/PODAT/PODAT8.html.
  9. "State Issue Brief No. 1: Current Alcohol Research in the Use of Medications as an Adjunct to Alcohol Treatment and Implications for State Alcohol Treatment Systems."  National Association of State Alcohol and Drug Abuse Directors, (Dec. 2001).  (Apr. 1, 2002), http://www.nasadad.org/Departments/Research/NIAAA,1stBrief.pdf.
  10. "Narcotic Antagonist Treatment Using Naltrexone."  National Institute on Drug Abuse, National Institutes of Health (Jan. 22, 2001).  (Apr. 1, 2002), http://165.112.78.61/PODAT/PODAT8.html#Narcotic.
  11. Ibid.
  12. "State Issue Brief No. 1."
  13. "Naltrexone, Coping Skills Prevent Relapse."  Join Together, (Jan. 10, 2002).  (Apr. 1, 2002), http://www.jointogether.org/sa/news/summaries/print/0,1856,547589,00.html.
  14. "Stiffer Controls Are Considered For Potential Heroin Treatment," Substance Abuse Letter (Pace Publications) 7, no. 15 (2002):  7.
  15. "Buprenorphine May Soon Be Heroin Treatment Option."  (Jan./Feb. 1995).  (Apr. 1, 2002), <http://165.112.78.61/NIDA_Notes/NNVol10N1/Bupren.html>.
  16. Ibid.
  17. Ibid.
  18. Ibid.

Bibliography

  • Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, The State of Methadone Treatment in a National Sample, Presented at American Methadone Treatment Association Conference, St. Louis, Missouri, Oct. 7-10, 2001, Presented by Wendee M. Wechsberg, Ph.D., Lary Crum, Ph.D., Amy Roussel, Ph.D., and Gary Zarkin, Ph.D.
  • Gelber, S.  Medication-Assisted Treatments for Drug and Alcohol Problems:  Reimbursement by Purchasers and Payors.  Berkeley, Ca.:  SGR Health, Ltd., 2001.
  • Gelber S.  Reimbursing Pharmaceutical Interventions for Substance Use Disorders.  Berkeley, Ca.:  SGR Health, Ltd., 2001.
  • Gelber, S., and David W. Rinaldo.  Strategies for Reimbursing Pharmaceutical Interventions for Substance Use Disorders.  Berkeley, Ca.:  SGR Health, Ltd., 2001.
  • National Institute on Drug Abuse, National Institutes of Health.  Principles of Drug Addiction Treatment:  A Research-Based Guide.  Washington, D.C.:  NIH, 1999.

Alcoholism

  • Chick, J., et al.  "A multicentre, randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of alcohol dependence or abuse."  Alcohol and Alcoholism 35, no. 6 (2000):  587-593.
  • Cornelius, J.R., et al.  "Fluoxetine in depressed alcoholics:  A double-blind, placebo-controlled trial."  Archives of General Psychiatry 54 (1997):  700-705.
  • Croop, R.S., et al.  "An open label usage study of naltrexone as adjunctive pharmacotherapy for individuals with alcoholism (Abstract)."  Alcohol Clinical Experimental Research Supplement 19, no. 2 (1995):  16A.
  • Durbin, P.; T. Hulot; and S. Chabac.  "Pharmacodynamics and pharmacokinetics of acamprosate:  An overview."  Quoted in M. Soyka (ed.), Acamprosate in Relapse Prevention of Alcoholism.  Berlin, Germany:  Springer-Verlag, 1996.
  • Fuller, R.K., et al.  "Disulfiram treatment of alcoholism:  A Veterans Administration Cooperative Study."  Journal of the American Medical Association 256 (1986):  1449-1489.
  • Fuller R.K., and H.P. Roth.  "Disulfiram for the treatment of alcoholism:  An evaluation in 128 men."  Annals of Internal Medicine 90 (1979):  901-904.
  • Geerlings, P.J.; C. Ansom; and W. Van Den Brink.  "Acamprosate and prevention of relapse in alcoholics."  European Addiction Research 3, no. 3 (1997):  129-137.
  • Johnson, B.A., and N. Ait-Daoud.  "Medications to treat alcoholism."  The Journal of the National Institute on Alcohol Abuse and Alcoholism 23, no. 2 (1999):  99-106.
  • Kranzler, H.R., et al.  "Placebo controlled trial of fluoxetine as an adjunct to relapse prevention in alcoholics."  American Journal of Psychiatry 152, no. 3 (1995):  391-397.
  • Mason, B.J., et al.  "A double-blind, placebo controlled study of oral nalmefene for alcohol dependence."  Archives of General Psychiatry 56, no. 8 (1997):  719-724.
  • Mason, B.J., and A.M. Goodman.  Brief Interventions and Medications Compliance Procedures:  Therapies Manual.  New York, N.Y.:  Lipha Pharmaceuticals Inc., 1997.
  • Mason, B.J., and R.L. Ownby.  "Acamprosate for the treatment of alcohol dependence:  A review of double-blind, placebo-controlled trial."  CNS Spectrums 5, no. 2 (2000):  58-69.
  • McCaul, M.E., et al.  "Naltrexone alters subjective and psychomotor responses to alcohol in heavy drinking subjects."  Neuropsychopharmacology 22, no. 5 (2000):  480-492.
  • Monti, P.M., et al.  "Naltrexone and cue exposure with coping and communications skills training for alcoholics:  Treatment process and 1-year outcomes."  Alcoholism Clinical and Experimental Research 25, no. 11 (2001):  1-14.
  • National Association of State Alcohol and Drug Abuse Directors.  Alcohol and Other Drug Treatment Effectiveness, A Review of State Outcome Studies.  Washington, D.C.:  NASADAD, 2001.
  • National Association of State Alcohol and Drug Abuse Directors.  State Issue Brief No. 1:  Current Alcohol Research in the use of Medications as an Adjunct to Alcohol Treatment and Implications for State Alcohol Treatment Systems.  Washington, D.C.:  NASADAD, 2001.
  • National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health. 10th Special Report to the U.S. Congress on Alcohol and Health.  Bethesda, Md.:  NIAAA, 2000.
  • ________________.  "New advances in alcoholism treatment."  Alcohol Alert.  Bethesda, MD:  NIAAA, 2000.
  • ________________.  "NIAAA launches COMBINE clinical trials."  National Institute on Alcohol Abuse and Alcoholism, NIH News Release.  Washington, D.C.:  NIH, 2001.
  • ________________.  "Orientation to naltrexone and the integration of medications into state treatment systems."  National Institute on Alcohol Abuse and Alcoholism Workshop, National Association of State Alcohol and Drug Abuse Directors Annual Meeting.  New Orleans, La.:  NIAAA, 2001.
  • O'Malley, S.S., et al.  "Naltrexone in the treatment of alcohol dependence:  A combined analysis of two trials."  Psychiatric Annals 25, no. 11 (1995):  681-688.
  • ________________.  "Naltrexone and coping skills therapy for alcohol dependence:  A controlled study."  Archives of General Psychiatry 49, no. 11 (1992):  881-887.
  • Paille, F.M., et al.  "Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol."  Alcohol and Alcoholism 30 (1995):  239-247.
  • Pettinati, H.M., et al.  "Double-blind clinical trial of sertraline treatment for alcohol dependence."  Journal of Clinical Psychopharmacology 21, no. 2 (2001):  143-153.
  • "Pharmacotherapy for Alcohol Dependence," URL=http://www.ahrq.gov/clinic/epcsums/alcosumm.htm; World Wide Web.
  • Project MATCH Research Group.  "Matching alcoholism treatments to client heterogeneity:  Project MATCH post-treatment drinking outcomes."  Journal of Studies on Alcohol 58 (1997):  7-29.
  • Sass, H., et al.  "Results from a placebo-controlled study on alcohol dependence."  Archives of General Psychiatry  53 (1996):  673-680.
  • Swift, R.M.  "Effect of naltrexone on human alcohol consumption."  Journal of Clinical Psychiatry 56, supp. 7 (1995):  24-29.
  • ________________.  "Medications and alcohol craving."  National Institute on Alcohol Abuse and Alcoholism 23, no. 2 (1999):  207-313.
  • Swift, R.M., et al.  "Naltrexone induced alterations in human ethanol intoxication."  American Journal of Psychiatry 151, no. 10 (1994):  163-1467.
  • Volpicelli, J.R., et al.  "Naltrexone in the treatment of alcohol dependence."  Archives of General Psychiatry 49 (1992):  876-880.
  • ________________.  "Naltrexone and alcohol dependence:  Role of subject compliance."  Archives of General Psychiatry 54, no. 8 (1997):  737-742.
  • ________________.  "Effect of naltrexone on alcohol 'high' in alcoholics."  American Journal of Psychiatry 152, no. 4 (1995):  613-615.
  • Whitworth, A.B., et al.  "Comparison of acamprosate and placebo in long-term treatment of alcohol dependence."  Lancet 347, no. 9013 (1996):  1438-1442.
  • Wilde, M.I., and A.J. Wagstaff.  "Acamprosate:  A review of its pharmacology and clinical potential in the management of alcohol dependence after detoxification."  Drugs 53, no. 6 (1997):  1038-1053.

Methadone

  • Ball, J.C., and A. Ross.  The Effectiveness of Methadone Treatment.  New York:  Springer-Verlag, 1991.
  • Cooper, J.R.  "Ineffective use of psychoactive drugs; Methadone treatment is no exception."  JAMA 267, no. 2 (1992):  281-282.
  • Dole, V.P.; M. Nyswander; and M.J. Kreek.  "Narcotic Blockade."  Archives of Internal Medicine 118 (1996):  304-309.
  • McLellan, A.T., et al.  "The effects of psychosocial services in substance abuse treatment."  JAMA 269, no. 15 (1993):  1953-1959.
  • Novick, D.M., et al.  "Absence of antibody to human immunodeficientcy virus in long-term, socially rehabilitated methadone maintenance patients."  Archives of Internal Medicine 150, no. 1 (1990):  97-99.
  • Simpson, D.D.  "Treatment for drug abuse; Follow-up outcomes and length of time spent.  Archives of General Psychiatry 38, no. 8 (1981):  875-880.
  • Simpson, D.D.; G.W. Joe; and S.A. Bracy.  "Six-year follow-up of opioid addicts after admission to treatment."  Archives of General Psychiatry 39, no. 11 (1982):  1318-1323.

Naltrexone

  • Cornish, J.W., et al.  "Naltrexone pharmacotherapy for opioid dependent federal probationers."  Journal of Substance Abuse Treatment 14, no. 6 (1997):  529-534.
  • Greenstein, R.A., et al.  "Naltrexone:  a clinical perspective."  Journal of Clinical Psychiatry 45, no. 9 part 2 (1984):  25-28.
  • Resnick, R.B.; E. Schuyten-Resnick; and A.M. Washton.  "Narcotic antagonists in the treatment of opioid dependence:  review and commentary."  Comprehensive Psychiatry 20, no. 2 (1979):  116-125.
  • Resnick, R.B., and A.M. Washton.  "Clinical outcome with naltrexone:  predictor variables and follow-up status in detoxified heroin addicts."  Annals of the New York Academy of Sciences 311 (1978):  241-246.

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