Opioid-Related Disorders Clinical Trial
Official title:
Opioid Maintenance: Optimum Stabilization and Withdrawal
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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