Effects of Aripiprazole on Cocaine Craving and Self-Administration
|ClinicalTrials.gov Identifier: NCT00373880|
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Abuse||Drug: Aripiprazole + Cocaine Drug: Placebo + Cocaine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||In order to achieve steady-state concentrations, participants (n=8 men) were administered placebo and aripiprazole (15 mg/day) capsules in counter-balanced order for 21 days. A smoked cocaine dose-response curve (0, 12, 25, 50 mg) was determined twice under placebo and aripiprazole maintenance.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Aripiprazole on Cocaine Craving and Self-Administration|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||September 2008|
Experimental: Aripiprazole (15mg) + Cocaine
Aripiprazole (15 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg).
Drug: Aripiprazole + Cocaine
Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Other Name: Active
Placebo Comparator: Placebo + Cocaine
Placebo (0 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Drug: Placebo + Cocaine
Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Other Name: Placebo
- Cocaine Self-administration [ Time Frame: 5 days ]
Mean number of cocaine choices as a function of cocaine dose and aripiprazole dose (n=8).
Participants sampled the dose of cocaine available for the session and then had five choices to respond for money ($5.00) or cocaine using a modified progressive-ratio schedule.
- Subjective Effects of Cocaine [ Time Frame: 5 days ]
Mean Visual Analog Scale (VAS) ratings (items: "Quality", "Pay for Dose", "Good Drug Effect", and "Cocaine Craving") from 0-100mm as a function of cocaine dose and aripiprazole dose 4 min following a single administration of cocaine (the "sample dose") at the start of the session.
For "Quality" item, the perceived quality of the drug is rated. The higher the rating, the better quality the drug was perceived to be.
For "Pay for Dose" item, the likelihood that the participant would pay for the drug is indicated. Higher ratings indicate a better likelihood that the person would pay for the dose received.
For "Good Drug Effect", the likelihood of feeling a good drug effect is indicated. The higher the number, the more of a good drug effect the person reported.
For "Cocaine Craving", the intensity of craving is reported. Higher scores indicate more craving for cocaine.
- Plasma Cocaine [ Time Frame: 8 minutes ]Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373880
|United States, New York|
|Irving Center for Clinical Research|
|New York, New York, United States, 10032|
|Principal Investigator:||Margaret Haney, Ph.D.||New York State Psychiatric Institute|