Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000457
Status:
COMPLETED
Last Update Posted:
2013-10-21
First Post:
1999-11-02
Brief Title:
Pharmacologic Relapse Prevention for Alcoholic Smokers
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pharmacologic Relapse Prevention for Alcoholic Smokers
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This study will compare the long-term use of bupropion Wellbutrin and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch The patch dose is projected to serve as a 100-percent replacement
Detailed Description:
The purpose of this trial was to recruit 292 recovering alcoholic smokers abstinent from alcohol for a minimum of 1 year who want to stop smoking and provide them with 100 nicotine replacement The 100 nicotine replacement will be undertaken using a nicotine patch By measuring their nicotine levels at study entry we can determine the patch dosing needed The patch dosing will vary from 22 mg to 44 mg Those who are able to achieve tobacco abstinence by week 8 will enter a relapse prevention phase for the remaining 44 weeks In this phase they will be randomized to active or placebo bupropion 300 mgday After 44 weeks of the relapse prevention trial at week 52 of study participation they will enter a post medication follow up for 6 months
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 |
|---|---|---|---|
| R01AA011219 | NIH | None | httpsreporternihgovquickSearchR01AA011219 |