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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Heroin Dependence; Opioid-Related Disorders

Treatments: Drug: Levoacetyl Methadol

Study type: Interventional

Funder types: NIH

Identifiers

NCT00218127

NIDA-13664-1

R01-13664-1

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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142 participants in 3 patient groups

1

Experimental group

Description:

LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks

Treatment:

Drug: Levoacetyl Methadol

Drug: Levoacetyl Methadol

Drug: Levoacetyl Methadol

2

Experimental group

Description:

LAAM MaxEffect to 48 mg Adjust to effect (+/-)

Treatment:

Drug: Levoacetyl Methadol

Drug: Levoacetyl Methadol

Drug: Levoacetyl Methadol

3

Experimental group

Description:

LAAM Fixed Dose up to 48 mg 48 mg

Treatment:

Drug: Levoacetyl Methadol

Drug: Levoacetyl Methadol

Drug: Levoacetyl Methadol