Aripiprazole Effects on Alcohol Drinking and Craving
|ClinicalTrials.gov Identifier: NCT01292057|
Recruitment Status : Completed
First Posted : February 9, 2011
Results First Posted : July 7, 2017
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Aripiprazole Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication|
|Study Start Date :||February 2011|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Active Comparator: Aripiprazole
Aripiprazole(up to 15 mg/day) for 8 days
Other Name: Abilify
|Placebo Comparator: Sugar pill||
Placebo to match active drug Aripiprazole for 8 days
- Total Number of Drinks Per Day During Natural (Usual Environment) Conditions [ Time Frame: 6-day observation period ]"Natural" alcohol consumption period -- drinks per day consumed during the 6-day observation period
- Total Number of Drinks Consumed in Bar Lab [ Time Frame: 2 hours during the bar lab paradigm ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292057
|United States, South Carolina|
|Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Raymond Anton, M.D.||Medical University of South Carolian|