Heroin Dependence, Opioid-Related Disorders
Conditions
Keywords
drug dependence
Brief summary
The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
Detailed description
Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
Interventions
DRUGHeroin Dependence
Sponsors
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
Individual must be currently 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 | — |
| Compliance | — |
| Dosing schedule preferences | — |
| Analog rating scale for dosing schedule effects | — |
Countries
United States
Outcome results
None listed