Trial Outcomes & Findings for Effects of Aripiprazole on Cocaine Craving and Self-Administration (NCT NCT00373880)

Last Updated: 2017-09-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

5 days

Results posted on

2017-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Aripiprazole/Placebo, Cocaine aripiprazole (15 mg/day) or placebo (0mg/day) + smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Overall Study STARTED	26
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole/Placebo, Cocaine aripiprazole (15 mg/day) or placebo (0mg/day) + smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Overall Study Physician Decision	3
Overall Study Arrested	1
Overall Study Protocol Violation	14

Baseline Characteristics

Effects of Aripiprazole on Cocaine Craving and Self-Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole vs. Placebo n=8 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Eight participants were included in this within-subjects analysis.

Outcome measures

Outcome measures
Measure	Placebo + 0mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.	Placebo + 12mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.	Placebo + 25mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.	Placebo + 50mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.	Aripiprazole + 0 mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.	Aripiprazole + 12mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.	Aripiprazole + 25mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.	Aripiprazole + 50mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
Cocaine Self-administration	0 Number of Choices Standard Error 0	1.5 Number of Choices Standard Error 0.5	3 Number of Choices Standard Error 0.5	4 Number of Choices Standard Error 0.5	0.2 Number of Choices Standard Error 0.1	2.8 Number of Choices Standard Error 0.5	3.9 Number of Choices Standard Error 0.5	3.7 Number of Choices Standard Error 0.5

SECONDARY outcome

Timeframe: 5 days

Population: Eight participants were included in this within-subjects analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo + 0mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.	Placebo + 12mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.	Placebo + 25mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.	Placebo + 50mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.	Aripiprazole + 0 mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.	Aripiprazole + 12mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.	Aripiprazole + 25mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.	Aripiprazole + 50mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
Subjective Effects of Cocaine Quality	0 Scores on a scale of 0-100mm Standard Error 0	8.5 Scores on a scale of 0-100mm Standard Error 0.5	32 Scores on a scale of 0-100mm Standard Error 5	38.5 Scores on a scale of 0-100mm Standard Error 6	0 Scores on a scale of 0-100mm Standard Error 0	10 Scores on a scale of 0-100mm Standard Error 0.4	25 Scores on a scale of 0-100mm Standard Error 5	37 Scores on a scale of 0-100mm Standard Error 6
Subjective Effects of Cocaine Pay for Dose	0 Scores on a scale of 0-100mm Standard Error 0	1.4 Scores on a scale of 0-100mm Standard Error 0.5	5 Scores on a scale of 0-100mm Standard Error 1	5.75 Scores on a scale of 0-100mm Standard Error 1	0 Scores on a scale of 0-100mm Standard Error 0	1.6 Scores on a scale of 0-100mm Standard Error 0.2	2.9 Scores on a scale of 0-100mm Standard Error 0.3	6 Scores on a scale of 0-100mm Standard Error 1.5
Subjective Effects of Cocaine Good Drug Effect	1 Scores on a scale of 0-100mm Standard Error 0.1	11 Scores on a scale of 0-100mm Standard Error 2	29 Scores on a scale of 0-100mm Standard Error 5	42 Scores on a scale of 0-100mm Standard Error 5	2 Scores on a scale of 0-100mm Standard Error 0.1	16 Scores on a scale of 0-100mm Standard Error 3	30.5 Scores on a scale of 0-100mm Standard Error 5	35 Scores on a scale of 0-100mm Standard Error 6
Subjective Effects of Cocaine Cocaine Craving	20 Scores on a scale of 0-100mm Standard Error 5	28 Scores on a scale of 0-100mm Standard Error 5	30 Scores on a scale of 0-100mm Standard Error 5	38.5 Scores on a scale of 0-100mm Standard Error 5	26 Scores on a scale of 0-100mm Standard Error 6	30 Scores on a scale of 0-100mm Standard Error 5	36 Scores on a scale of 0-100mm Standard Error 6	33.5 Scores on a scale of 0-100mm Standard Error 6

SECONDARY outcome

Timeframe: 8 minutes

Population: Eight participants were included in this within-subjects analysis.

Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.

Outcome measures

Outcome measures
Measure	Placebo + 0mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 0 mg cocaine.	Placebo + 12mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 12 mg cocaine.	Placebo + 25mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 25 mg cocaine.	Placebo + 50mg Cocaine n=8 Participants Participants received placebo (0 mg/day) in conjunction with 50 mg cocaine.	Aripiprazole + 0 mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 0 mg cocaine.	Aripiprazole + 12mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 12 mg cocaine.	Aripiprazole + 25mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 25 mg cocaine.	Aripiprazole + 50mg Cocaine n=8 Participants Participants received aripiprazole (15 mg/day) in conjunction with 50 mg cocaine.
Plasma Cocaine	32 ng/mL Standard Deviation 2	60 ng/mL Standard Deviation 4	67 ng/mL Standard Deviation 4	119 ng/mL Standard Deviation 12	18 ng/mL Standard Deviation 1	36 ng/mL Standard Deviation 3	75 ng/mL Standard Deviation 5	130 ng/mL Standard Deviation 10

Adverse Events

Aripiprazole vs. Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Haney, Ph.D.

New York State Psychiatric Institute at Columbia University Medical Center

Phone: 646-774-6153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place