NCT00218127

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

Opioid Maintenance: Optimum Stabilization and Withdrawal

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Heroin Dependence
• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Levoacetyl Methadol	WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
DRUG	Levoacetyl Methadol	MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
DRUG	Levoacetyl Methadol	LAAM Fixed Dose evaluation up to 48 mg 48 mg

Timeline

• Start date: 2001-11-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2005-09-22
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States