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Effects of Aripiprazole on Cocaine Craving and Self-Administration

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ClinicalTrials.gov Identifier: NCT00373880
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cocaine Abuse
Interventions Drug: Aripiprazole + Cocaine
Drug: Placebo + Cocaine
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole/Placebo, Cocaine
Hide Arm/Group Description aripiprazole (15 mg/day) or placebo (0mg/day) + smoked cocaine dose–response curve (0, 12, 25, 50 mg)
Period Title: Overall Study
Started 26
Completed 8
Not Completed 18
Reason Not Completed
Physician Decision             3
Arrested             1
Protocol Violation             14
Arm/Group Title Aripiprazole vs. Placebo
Hide Arm/Group Description Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) or placebo (o mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
41.8  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
0
   0.0%
Male
8
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  62.5%
White
3
  37.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Cocaine Self-administration
Hide Description

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.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eight participants were included in this within-subjects analysis.
Arm/Group Title Placebo + 0mg Cocaine Placebo + 12mg Cocaine Placebo + 25mg Cocaine Placebo + 50mg Cocaine Aripiprazole + 0 mg Cocaine Aripiprazole + 12mg Cocaine Aripiprazole + 25mg Cocaine Aripiprazole + 50mg Cocaine
Hide Arm/Group Description:
Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8
Mean (Standard Error)
Unit of Measure: Number of Choices
0  (0) 1.5  (0.5) 3  (0.5) 4  (0.5) 0.2  (0.1) 2.8  (0.5) 3.9  (0.5) 3.7  (0.5)
2.Secondary Outcome
Title Subjective Effects of Cocaine
Hide Description

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.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eight participants were included in this within-subjects analysis.
Arm/Group Title Placebo + 0mg Cocaine Placebo + 12mg Cocaine Placebo + 25mg Cocaine Placebo + 50mg Cocaine Aripiprazole + 0 mg Cocaine Aripiprazole + 12mg Cocaine Aripiprazole + 25mg Cocaine Aripiprazole + 50mg Cocaine
Hide Arm/Group Description:
Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8
Mean (Standard Error)
Unit of Measure: Scores on a scale of 0-100mm
Quality 0  (0) 8.5  (0.5) 32  (5) 38.5  (6) 0  (0) 10  (0.4) 25  (5) 37  (6)
Pay for Dose 0  (0) 1.4  (0.5) 5  (1) 5.75  (1) 0  (0) 1.6  (0.2) 2.9  (0.3) 6  (1.5)
Good Drug Effect 1  (0.1) 11  (2) 29  (5) 42  (5) 2  (0.1) 16  (3) 30.5  (5) 35  (6)
Cocaine Craving 20  (5) 28  (5) 30  (5) 38.5  (5) 26  (6) 30  (5) 36  (6) 33.5  (6)
3.Secondary Outcome
Title Plasma Cocaine
Hide Description Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.
Time Frame 8 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Eight participants were included in this within-subjects analysis.
Arm/Group Title Placebo + 0mg Cocaine Placebo + 12mg Cocaine Placebo + 25mg Cocaine Placebo + 50mg Cocaine Aripiprazole + 0 mg Cocaine Aripiprazole + 12mg Cocaine Aripiprazole + 25mg Cocaine Aripiprazole + 50mg Cocaine
Hide Arm/Group Description:
Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.
Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.
Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
32  (2) 60  (4) 67  (4) 119  (12) 18  (1) 36  (3) 75  (5) 130  (10)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole vs. Placebo Placebo
Hide Arm/Group Description Aripiprazole + Cocaine: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg). Placebo + Cocaine: Participants received placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
All-Cause Mortality
Aripiprazole vs. Placebo Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole vs. Placebo Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole vs. Placebo Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
The study did not assess whether the medication would be useful in preventing relapse in abstinent cocaine users or whether aripiprazole would be beneficial to cocaine-dependent individuals being treated for a psychiatric comorbidity.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Margaret Haney, Ph.D.
Organization: New York State Psychiatric Institute at Columbia University Medical Center
Phone: 646-774-6153
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00373880     History of Changes
Other Study ID Numbers: 4741
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: August 3, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017