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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA010761 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer) is effective in reducing of alcohol craving and drinking compared to placebo depending on participant's baseline level of impulsivity.
Non-treatment seeking individuals meeting criteria for alcohol dependence (N=120) will be recruited through advertisement and paid for their participation. Subjects will have blood drawn for DNA analysis of various brain dopamine system genes. Alcoholics, after baseline evaluation, will be assigned through urn randomization to one of two experimental groups, depending on their baseline level of impulsivity, 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 (functional magnetic resonance imaging) brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. fMRI (functional magnetic resonance) imaging 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.
Whether dopamine system genetic differences will be predict drinking, nucleus accumbens activity, and aripiprazole response will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Active Comparator | Medication |
|
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Aripiprazole(up to 15 mg/day) for 8 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Drinks Per Day During Natural (Usual Environment) Conditions | "Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period | 6-day observation period |
| Total Number of Drinks Consumed in Bar Lab | This measure refers to a "bar lab" paradigm in which individuals received an initial "priming" drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8. | 2 hours during the bar lab paradigm |
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Inclusion Criteria:
Inclusion for fMRI (functional magnetic resonance imaging) Imaging:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Anton, M.D. | Medical University of South Carolian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28493623 | Background | Anton RF, Schacht JP, Voronin KE, Randall PK. Aripiprazole Suppression of Drinking in a Clinical Laboratory Paradigm: Influence of Impulsivity and Self-Control. Alcohol Clin Exp Res. 2017 Jul;41(7):1370-1380. doi: 10.1111/acer.13417. Epub 2017 Jun 5. |
| Label | URL |
|---|---|
| Alcoholism | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Medication Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days |
| FG001 | Sugar Pill | Placebo: Placebo to match active drug Aripiprazole for 8 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Medication Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days |
| BG001 | Sugar Pill | Placebo: Placebo to match active drug Aripiprazole for 8 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Drinks Per Day During Natural (Usual Environment) Conditions | "Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period | Posted | Mean | Standard Error | standard drinks | 6-day observation period |
|
|
8 days
Adverse event defined as any symptom rated "moderate" or "severe" on a 21-item physical symptom checklist. Items from the checklist were: trouble sleeping, daytime sleepiness, nervousness, irritability, trouble concentrating, feeling depressed, abdominal pain, nausea/vomiting, constipation, joint pain, headache, dizziness, low energy, skin rash, ears ringing, vision blurry, itching, increased libido, decreased libido, difficulty reaching orgasm, and inability to reach orgasm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole | Medication Aripiprazole: Aripiprazole(up to 15 mg/day) for 8 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trouble sleeping | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Schacht, Ph.D. | Medical University of South Carolina | (843) 792-7497 | schacht@musc.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D007175 | Impulsive Behavior |
| 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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| Placebo | Drug | Placebo to match active drug Aripiprazole for 8 days |
|
| Ethanol | View source |
| Aripiprazole | View source |
| Clinical trials | View source |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Total Number of Drinks Consumed in Bar Lab | This measure refers to a "bar lab" paradigm in which individuals received an initial "priming" drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8. | Posted | Mean | Standard Error | bar lab drinks | 2 hours during the bar lab paradigm |
|
|
|
| 0 |
| 47 |
| 39 |
| 47 |
| EG001 | Sugar Pill | Placebo: Placebo to match active drug Aripiprazole for 8 days | 0 | 48 | 17 | 48 |
| Daytime sleepiness | Nervous system disorders | Systematic Assessment |
|
| Nervousness | Nervous system disorders | Systematic Assessment |
|
| Irritability | Nervous system disorders | Systematic Assessment |
|
| Trouble concentrating | Nervous system disorders | Systematic Assessment |
|
| Feeling depressed | Psychiatric disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Low energy | Nervous system disorders | Systematic Assessment |
|
| Increased libido | Reproductive system and breast disorders | Systematic Assessment |
|
| Decreased libido | Reproductive system and breast disorders | Systematic Assessment |
|
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| D001519 | Behavior |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |