Phase 1
N=30
Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
Cocaine Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02522325 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative — .34; .24; 4.31; 3.9 Cocaine Choices
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Phendimetrazine (Drug); Cocaine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- William Stoops
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative |
.34; .24; 4.31; 3.9; 4.69; 3.83 | — |
Summary
This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
Eligibility Criteria
Inclusion Criteria
- Recent cocaine use
Exclusion Criteria
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine or phendimetrazine
Data sourced from ClinicalTrials.gov (NCT02522325). 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.