Clinical Trial: Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Opioid Maintenance: Optimum Stabilization and Withdrawal

Brief Summary: Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.

Detailed Summary:

Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.

This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.

Sponsor: National Institute on Drug Abuse (NIDA)

Current Primary Outcome: drug use [ Time Frame: herion use over 20 week period ]

Original Primary Outcome: Substance use and retention

Current Secondary Outcome:

Original Secondary Outcome: Behavioral and pyschological measures during stable dosing and dose reduction

Information By: National Institute on Drug Abuse (NIDA)

Dates:
Date Received: September 16, 2005
Date Started: November 2001
Date Completion:
Last Updated: January 11, 2017
Last Verified: October 2016