Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256451
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2005-11-17
Brief Title:
Endophenotype for Alcohol Misuse in Healthy Minority Populations
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Defining an Endophenotype for Alcohol Misuse A Focus On Minority Populations
Status:
COMPLETED
Status Verified Date:
2019-08
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:
DEFINE
Brief Summary:
The purpose of the study is to understand the relationship between what an individual inherited from their family genetics how they respond and feel after drinking alcohol and how they respond to pre-treatment with naltrexone a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics The investigators seek to enroll 40 people in the study Participation will consist of 4 different alcohol challenge sessions in a cross over design Each session will be separated by at least 10 days In total there will be four challenge sessions
Detailed Description:
We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment To meet this aim non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers After consenting genotyping and completing the baseline assessment they will participate in four separate alcohol challenge sessions separated by at least 10 days During each of the sessions subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone 50 mgday or placebo in a double-blind fashion The order of the four sessions will be randomly assigned During each session physiological and subjective response will be measured We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele
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