Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT00330434
Status:
WITHDRAWN
Last Update Posted:
2020-11-10
First Post:
2006-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
Human CYP2B6: Induction by Ethanol and Polymorphisms
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The two purposes of this study are
1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has
1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
2. on the stimulant effect of bupropion and
2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has
1. on the blood levels of bupropion and its major breakdown products in the blood and
2. on the stimulant effect of bupropion.
Two groups of volunteers will be recruited for this study:
1. volunteers who drink moderate to heavy amounts of alcohol frequently and
2. volunteers who usually do not drink alcohol.
Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has
1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
2. on the stimulant effect of bupropion and
2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has
1. on the blood levels of bupropion and its major breakdown products in the blood and
2. on the stimulant effect of bupropion.
Two groups of volunteers will be recruited for this study:
1. volunteers who drink moderate to heavy amounts of alcohol frequently and
2. volunteers who usually do not drink alcohol.
Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| F32AA015647-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |
| 1F32AA015647-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |