Phase 3
N=302
Cocaine Use Reduction With Buprenorphine
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01402492 ↗Enrolled (actual)
302
Serious AEs
10.9%
Results posted
Oct 2021
Primary outcome: Primary: Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens — 6.6; 7.2; 7.7 days of cocaine use
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine + Naltrexone (Drug); Placebo + Naltrexone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens |
6.6; 7.2; 7.7 | — |
Summary
The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.
Eligibility Criteria
Inclusion Criteria
- 18 to 65 years of age
- In good general health
- Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence
- Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime
- Interested in receiving treatment for cocaine dependence
- Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
- Able to satisfy and comply with study procedures and requirements
- If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study
Exclusion Criteria
- Pregnant or breastfeeding females
- Known allergy or sensitivity to study medications
- Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation
- Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation
- Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values
- Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe
- Pending action or situation that might prevent remaining in the area for the duration of the study
Data sourced from ClinicalTrials.gov (NCT01402492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.