There are two main pharmacotherapy agents used in the maintenance treatment of opioid addicts: the narcotic agonist methadone and the narcotic antagonist, naltrexone. Each treatment has limitations: for naltrexone, poor patient retention, and for methadone maintenance, continued illicit opioid use in patients maintained on relatively low methadone doses and poor success at detoxification. Given these difficulties with each maintenance treatment, this study was designed to evaluate a new maintenance agent - buprenorphine, a mixed agonist/antagonist. Unlike other opioid agonists, buprenorphine does not lead to significant physical dependence in man and appears to prevent narcotic euphoria and physical dependence through both cross tolerance and competitive antagonism. This study compares the efficacy of buprenorphine maintenance (4 mg daily with possible increase to 8 mg) to methadone maintenance (35 mg daily with possible increase to 65 mg) in a 6-month outpatient maintenance program using a double blind, random assignment trial. One hundred and twenty (120) patients will be used to assess efficacy, as defined relative to treatment retention, illicit drug use, and symptom levels (withdrawal, depression, and anxiety) during the 6-month trial. Data analyses will involve life table analysis of length of time in treatment and time remaining abstinent from illicit drugs, as well as analysis of variance for repeated measures on the withdrawal symptom, depression and anxiety scores comparing the buprenorphine to the methadone maintained group. We hypothesize that although buprenorphine may be no better than methadone in retaining patients in treatment, it will be superior in rates of abstinence from illicit drugs during the 6 months of maintenance and/or in successful detoxification to a medication-free state during the 6 month follow-up.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA005626-03
Application #
3212125
Study Section
Special Emphasis Panel (SRCD (04))
Project Start
1988-08-01
Project End
1992-07-31
Budget Start
1990-08-01
Budget End
1991-07-31
Support Year
3
Fiscal Year
1990
Total Cost
Indirect Cost
Name
Yale University
Department
Type
Schools of Medicine
DUNS #
082359691
City
New Haven
State
CT
Country
United States
Zip Code
06520
Stotts, Angela L; Dodrill, Carrie L; Kosten, Thomas R (2009) Opioid dependence treatment: options in pharmacotherapy. Expert Opin Pharmacother 10:1727-40
Sofuoglu, Mehmet; Poling, James; Gonzalez, Gerardo et al. (2007) Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study. Exp Clin Psychopharmacol 15:453-60
Gonzalez, Gerardo; Desai, Rani; Sofuoglu, Mehmet et al. (2007) Clinical efficacy of gabapentin versus tiagabine for reducing cocaine use among cocaine dependent methadone-treated patients. Drug Alcohol Depend 87:1-9
Poling, James; Oliveto, Alison; Petry, Nancy et al. (2006) Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained population. Arch Gen Psychiatry 63:219-28
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Kosten, Thomas; Falcioni, Jean; Oliveto, Alison et al. (2004) Depression predicts higher rates of heroin use on desipramine with buprenorphine than with methadone. Am J Addict 13:191-201
Gonzalez, Gerardo; Sevarino, Kevin; Sofuoglu, Mehmet et al. (2003) Tiagabine increases cocaine-free urines in cocaine-dependent methadone-treated patients: results of a randomized pilot study. Addiction 98:1625-32
Kosten, Thomas; Oliveto, Alison; Feingold, Alan et al. (2003) Desipramine and contingency management for cocaine and opiate dependence in buprenorphine maintained patients. Drug Alcohol Depend 70:315-25
Sofuoglu, Mehmet; Gonzalez, Gerardo; Poling, James et al. (2003) Prediction of treatment outcome by baseline urine cocaine results and self-reported cocaine use for cocaine and opioid dependence. Am J Drug Alcohol Abuse 29:713-27

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