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

Study Overview
=================
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.

Official Title
-----------------
Opioid Maintenance: Optimum Stabilization and Withdrawal

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Levoacetyl Methadol
* Drug: Levoacetyl Methadol
* Drug: Levoacetyl Methadol


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks | Drug: Levoacetyl Methadol<br>* WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day<br>* Other names: LAAM;|
| Experimental: 2<br>LAAM MaxEffect to 48 mg Adjust to effect (+/-) | Drug: Levoacetyl Methadol<br>* MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)<br>* Other names: LAAM;|
| Experimental: 3<br>LAAM Fixed Dose up to 48 mg 48 mg | Drug: Levoacetyl Methadol<br>* LAAM Fixed Dose evaluation up to 48 mg 48 mg<br>* Other names: LAAM;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug use |  | herion use over 20 week period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heroin dependence