Early Phase 1
N=9
Impact of a Non-Drug Choice on Cocaine Reinforcement
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01906346 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative — 2.75; 1.38; 1.38; 4.75 cocaine choices
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Cocaine (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Joshua A. Lile, Ph.D.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative |
2.75; 1.38; 1.38; 4.75; 5.88; 4.00 | — |
Summary
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.
Eligibility Criteria
Inclusion Criteria
- Cocaine dependence, otherwise healthy
Exclusion Criteria
- Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Data sourced from ClinicalTrials.gov (NCT01906346). 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.