Phase 3
Completed N=302
Cocaine Use Reduction With Buprenorphine
Cocaine Dependence
Source: ClinicalTrials.gov NCT01402492 ↗
Enrolled (actual)
302
Serious AEs
10.9%
Results posted
Oct 2021
Primary outcomePrimary: 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
◆ Published Evidence
Established
71citations · ~7 / year
Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study.
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.
Linked Publications (2)
-
Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study.
-
Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.