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

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.

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)