Phase 2
N=179
A Multi-Center Trial of Nepicastat for Cocaine Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01704196 ↗Enrolled (actual)
179
Serious AEs
5.6%
Results posted
May 2017
Primary outcome: Primary: Abstinence (Weeks 10 - 11) — 4; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nepicastat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abstinence (Weeks 10 - 11) |
4; 7 | — |
| SECONDARY Reduction in Use (Weeks 1 - 11) |
13; 20 | — |
Summary
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years of age
- Is seeking treatment for cocaine dependence
- Is able to understand and provide written informed consent
- Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
- If female, agrees to use an acceptable method of birth control
- Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study
Exclusion Criteria
- Please contact the study site for more information
Data sourced from ClinicalTrials.gov (NCT01704196). 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.