Phase 2
Completed N=26
Effects of Aripiprazole on Cocaine Craving and Self-Administration
Cocaine Abuse
Source: ClinicalTrials.gov NCT00373880 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Cocaine Self-administration — 0; 1.5; 3; 4 Number of Choices
Summary
The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Self-administration |
0; 1.5; 3; 4; 0.2; 2.8 | — |
| SECONDARY Subjective Effects of Cocaine |
0; 8.5; 32; 38.5; 0; 10 | — |
| SECONDARY Plasma Cocaine |
32; 60; 67; 119; 18; 36 | — |
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV criteria for current cocaine abuse
- Average use of smoked cocaine is at least 2x/week for past 6 mos); currently spends at least $70 per week on cocaine
- Has patterns of smoked cocaine use in terms of frequency and amounts which parallel or exceed those administered in the study
- Age 21-45
- Able to give informed consent, and comply with study procedures
Exclusion Criteria
- Current seizure disorder, heart disease or psychiatric disorders (other than cocaine dependence)
- Dependence on substances other than cocaine or nicotine
- Request for drug treatment
- Judged to be noncompliant with study protocol
- Current use of any medication that has the potential to interact with aripiprazole (i.e., seizure medications, anti-fungal medications, cardiac medications, or medication that produces drowsiness)
- Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
- Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
- Current parole or probation
- History of significant violent or suicidal behavior
Data sourced from ClinicalTrials.gov (NCT00373880). 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.