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

Phase 2

Completed

• Conditions: Heroin Dependence; Opioid-Related Disorders
• Interventions: Drug: Levoacetyl Methadol

• Registration Number: NCT00218127
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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 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.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Status Verified: 2016-10
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Current opiate dependence
• Provides acceptable proof of identity
• History of 5 or more years of regular heroin use or dependence
• Reads and writes English

Exclusion Criteria

• Significant suicidal or homicidal ideation, intent, or plan
• Current AXIS I psychotic, depressive, or anxiety disorder
• Meets DSM-IV criteria for dependence on any drug other than nicotine
• Impending legal complications or incarceration
• On parole or probation that requires reports of drug use or research data
• Currently receiving treatment for opiate dependence
• Currently participating in a 12-step substance detoxification program
• Medical condition that contraindicates administration of ORLAAM
• Plans to leave Houston, Texas within the year following study entry
• Pregnant or breastfeeding
• History of heart problems, including heart arrhythmias
• Requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	Levoacetyl Methadol	LAAM Fixed Dose up to 48 mg 48 mg
2	Levoacetyl Methadol	LAAM MaxEffect to 48 mg Adjust to effect (+/-)
1	Levoacetyl Methadol	LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks

Primary Outcome Measures

Name	Time	Method
drug use	herion use over 20 week period

Trial Locations

Locations (1)

Department of Psychatiry, Mental Services; 🇺🇸 Houston, Texas, United States