A Phase 2 interventional study of Aripiprazole + Cocaine and Placebo + Cocaine in Cocaine Abuse, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.
Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action, progress towards the development of an effective pharmacological treatment for cocaine abuse has been disappointing. We are proposing to use our laboratory model of repeated dose cocaine self-administration to assess the potential efficacy of the novel antipsychotic, aripiprazole. Aripiprazole is a partial agonist at both the dopamine D2 receptor and at the serotonin 5HT1a receptor, while antagonizing the 5HT2a receptor. By functioning as a partial D2 agonist, aripiprazole is hypothesized to function as a D2 antagonist during hypodopaminergic states, such as during cocaine use, while functioning as a D2 agonist during hypodopaminergic states, such as during cocaine withdrawal. This 42-day, outpatient/inpatient/outpatient/inpatient protocol will evaluate the effects of aripiprazole maintenance (0, 15 mg/day) on cocaine craving, subjective effects, and self-administration using a within-subjects design. Non-treatment seeking cocaine abusers will be maintained outpatient for 16 days of dose maintenance prior to inpatient cocaine self-administration sessions. During the inpatient phases, volunteers will live on a hospital clinical research unit and will participate in laboratory sessions in which they will have the opportunity to choose between repeated doses of smoked cocaine and $5. In addition to measuring their cocaine self-administration, we will measure the cardiovascular and subjective effects of cocaine under each aripiprazole maintenance condition.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aripiprazole (15 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg).
Drug: Aripiprazole + Cocaine
Placebo (0 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Drug: Placebo + Cocaine
Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Also known as: Active
Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).
Also known as: Placebo
Cocaine Self-administration
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
Subjective Effects of Cocaine
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
Plasma Cocaine
Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.
Time frame: 8 minutes
| Milestone | Aripiprazole/Placebo, Cocaine |
|---|---|
| Started | 26 |
| Completed | 8 |
| Not completed | 18 |
| Withdrew: Physician decision | 3 |
| Withdrew: Arrested | 1 |
| Withdrew: Protocol violation | 14 |
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.
| Number of Choices | 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 |
|---|---|---|---|---|---|---|---|---|
| Cocaine Self-administration | 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 |
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.
| Scores on a scale of 0-100mm | 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
Mean plasma cocaine levels after a single administration of each cocaine dose as a function of aripiprazole and cocaine dose.
| ng/mL | 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 |
|---|---|---|---|---|---|---|---|---|
| Plasma Cocaine | 32 ± 2 | 60 ± 4 | 67 ± 4 | 119 ± 12 | 18 ± 1 | 36 ± 3 | 75 ± 5 | 130 ± 10 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aripiprazole vs. Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Aripiprazole vs. Placebo |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age, Continuous(years) | Aripiprazole vs. Placebo |
|---|---|
| Mean | 41.8 ± 3.9 |
| Sex: Female, Male(Participants) | Aripiprazole vs. Placebo |
|---|---|
| Female | 0 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | Aripiprazole vs. Placebo |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Aripiprazole vs. Placebo |
|---|---|
| United States | 8 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York State Psychiatric Institute