Heroin Dependence, Opioid-Related Disorders
Conditions
Keywords
drug dependence
Brief summary
The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.
Detailed description
S/A brief Summary for the Public
Interventions
DRUGOpioid-Related Disorders
Sponsors
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Exclusion criteria
Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug use | — |
| Retention | — |
| Opioid agonist rating | — |
| Opioid antagonist rating | — |
| Compliance | — |
| Medication identification | — |
| Addiction Severity Index (ASI) Composite Score Rating | — |
Countries
United States
Outcome results
None listed