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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA010761 | U.S. NIH Grant/Contract | View source | |
| NIH P50 AA010761 |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving compared to placebo.
Non-treatment seeking individuals meeting criteria for alcohol dependence (N=30) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will be assigned through urn randomization to one of two experimental groups in which they will receive either aripiprazole (up to 15 mg/day) or an identical placebo. Subjects will take the study drug or placebo for 8 days (day 1-6 being the natural observation period). After a minimum of 24 hours of abstinence from alcohol (day 7-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.
Each subject will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. fMRI brain imaging technology will be used to determine if alcoholics treated with aripiprazole differ in alcohol cue-induced activity in the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus accumbens activation to alcohol cues compared to placebo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aripiprazole (up to 15 mg/day) for 8 days | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| For the Efficacy Hypotheses, the primary dependent variables are | ||
| (First) "Natural" alcohol consumption period -- total number of drinks consumed during the 5-day observation period | ||
| (Second) Limited access alcohol consumption paradigm -- Total number of drinks consumed | ||
| (Third) Activation of nucleus accumbens after cue stimulation | ||
| For the Safety and Tolerability Hypotheses, the primary dependent variables are | ||
| (First) Number of drop-outs due to adverse events | ||
| (Second) Number of side effects on symptom checklist | ||
| (Third) Change in liver function as indicated by ALT, AST |
| Measure | Description | Time Frame |
|---|---|---|
| Blood alcohol levels after priming drink | ||
| Average BAES stimulation score | ||
| SHAS score after alcohol priming drink |
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Inclusion Criteria:
Age 21 - 65
Meets the DSM IV criterion for current alcohol dependence including "loss of control over drinking" (criterion 3 and/or 4).
Currently is not engaged in, and does not want treatment for, alcohol related problems.
Able to read and understand questionnaires and informed consent.
Lives within 50 miles of the study site.
Able to maintain abstinence for up to two days (without the aid of detox medications) as determined by self report and breathalyzer measurements.
*Inclusion for fMRI imaging:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond F. Anton, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Drug and Alcohol Programs, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Change in POMS sub-scale scores |
| Change in Epworth Sleepiness Scale |
| Differential effects on the Quality of Sleep Scale |
| Craving (OCDS) change between day 1 and 6 |
| Craving after alcohol priming |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |