Early Phase 1
N=18
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Active Cocaine Users
Bottom Line
View on ClinicalTrials.gov: NCT02383043 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative — 0.06; 0.94; 0.75; 0.88 cocaine choices
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Cocaine (Drug); Sustained Release d-Amphetamine (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Joshua A. Lile, Ph.D.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative |
0.06; 0.94; 0.75; 0.88; 2.50; 0.56 | — |
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 choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.
Eligibility Criteria
Inclusion Criteria
- Recent cocaine use, 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 (NCT02383043). 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.