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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2005-07-31

Brief Summary

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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.

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Detailed Description

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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

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Heroin Dependence Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Levoacetyl Methadol

Intervention Type DRUG

WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day

2

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

Group Type EXPERIMENTAL

Levoacetyl Methadol

Intervention Type DRUG

MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)

3

LAAM Fixed Dose up to 48 mg 48 mg

Group Type EXPERIMENTAL

Levoacetyl Methadol

Intervention Type DRUG

LAAM Fixed Dose evaluation up to 48 mg 48 mg

Interventions

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Levoacetyl Methadol

WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day

Intervention Type DRUG

Levoacetyl Methadol

MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)

Intervention Type DRUG

Levoacetyl Methadol

LAAM Fixed Dose evaluation up to 48 mg 48 mg

Intervention Type DRUG

Other Intervention Names

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LAAM LAAM LAAM

Eligibility Criteria

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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)

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes