Aripiprazole Effects on Alcohol Drinking and Craving
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication|
- total number of drinks per day during natural (usual environment) conditions [ Time Frame: 5-day observation period ] [ Designated as safety issue: No ]"Natural" alcohol consumption period -- drinks per day consumed during the 5-day observation period
- Total number of drinks under controlled conditions (bar lab) [ Time Frame: 2 hours during the alcohol challenge procedure ] [ Designated as safety issue: No ]Limited access alcohol consumption paradigm -- Total number of drinks consumed
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292057
|Contact: Konstantin F. Voronin, MD, PhDemail@example.com|
|Contact: Raymond F. Anton, MDfirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina, Institute of Psychiatry, Center for Drug and Alcohol Programs||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Konstantin E. Voronin, MD, PhD 843-792-4887 email@example.com|
|Principal Investigator:||Raymond Anton, M.D.||Medical University of South Carolian|