Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183222
Status:
COMPLETED
Last Update Posted:
2010-05-05
First Post:
2005-09-13
Brief Title:
Effectiveness of Naltrexone andor Ondansetron to Reduce Craving for Alcohol and Drinking
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Alcohol Research Center Grant Component 1 COMBINING MEDICATIONS ALCOHOL REACTIVITY AND CONSUMPTION
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 naltrexone an opiate blocking agent approved for the treatment of alcohol dependence ondansetron a serotonin 3 antagonist medication approved to treat nausea or their combination are effective in the reduction of alcohol craving and drinking compared to placebo
Detailed Description:
Non-treatment seeking individuals meeting criteria for alcohol dependence N160 will be recruited through advertisement and paid for their participation Alcoholics after baseline evaluation will be assigned through urn randomization using a double dummy placebo controlled design to one of four experimental groups naltrexone 50 mgday N40 ondansetron 025 mg twice a day N40 naltrexone and ondansetron N40 or placebos N40 Subjects will take the study drugs for 8 days day 1-5 being the natural observation period After a minimum of 48 hours of abstinence from alcohol day 6-8 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 offeredA subset of subjects from each medication group N15 will undergo a functional MRI brain scan with cue stimulation on day 7 on the evening before the alcohol administration paradigm
A smaller group of social drinker controls N16 recruited and paid in a similar fashion will be randomly assigned to the same medication groups 4 per group They will be used as procedure controls for the alcohol administration lab study and as a comparisoncontrast group for the brain imaging sub-study
A smaller group of social drinker controls N16 recruited and paid in a similar fashion will be randomly assigned to the same medication groups 4 per group They will be used as procedure controls for the alcohol administration lab study and as a comparisoncontrast group for the brain imaging sub-study
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 |
|---|---|---|---|
| P50AA010761 | NIH | None | None |
| NIH Grant P50 AA010761 | US NIH GrantContract | None | httpsreporternihgovquickSearchP50AA010761 |