Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183235
Status:
COMPLETED
Last Update Posted:
2010-05-05
First Post:
2005-09-13
Brief Title:
Aripiprazole Effects on Alcohol Reactivity and Consumption
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Effectiveness of Aripiprazole to Reduce Craving for Alcohol and Drinking Under Natural Observation During Cue Induced Brain Imaging and During a Motivated Free Choice Drinking Procedure Compared to Placebo
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether aripiprazole marketed dopamine stabilizer is effective in reducing of alcohol craving compared to placebo
Detailed Description:
Non-treatment seeking individuals meeting criteria for alcohol dependence N30 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 mgday 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH P50 AA010761 | US NIH GrantContract | None | httpsreporternihgovquickSearchP50AA010761 |
| P50AA010761 | NIH | None | None |