Heroin Dependence, Opioid-Related Disorders
Conditions
Keywords
Heroin dependence
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.
Interventions
DRUGLevoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| drug use | herion use over 20 week period |
Countries
United States
Outcome results
None listed