Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
- Conditions
- Opioid-Related DisordersHeroin Dependence
- Registration Number
- NCT00000326
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
- Detailed Description
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Individuals must be 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Drug effect characteristics Dose order estimate-nurse Dose order estimate-client Pupil diameter Retention Observed withdrawal rating Opioid antagonist rating Analog rating scale for drug effects Drug use Subjective dose estimate Opioid agonist rating Compliance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States