Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129311
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2005-08-09
Brief Title:
Usefulness of Selegiline as an Aid to Quit Smoking - 1
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Usefulness of Selegiline for Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence many smokers are still unable to quit smoking The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking
Detailed Description:
Despite the availability of nicotine replacement therapies and sustained-relapse bupropion for the treatment of nicotine dependence there is still a significant proportion of cigarette smokers who are unable to quit smoking Therefore new and effective pharmacotherapies for smoking cessation are needed The primary aim of this study is to determine the safety and efficacy of selegiline as an aid to smoking cessation
In this study 200 nicotine-dependent cigarette smokers will participate in an 8-week double-blind placebo-controlled trial and then will be followed over 4 years Participants will be randomly assigned to receive either selegiline or placebo Selegiline doses of 5 mg will be taken once a day during the first week This will be increased to 5 mg twice daily for the remaining 7 weeks The target smoking quit date will be Day 15 All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinics Smoke Free and Livin It program The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial Days 29-56 and 7-day point prevalence abstinence at the end of the 8-week trial Days 49-56
In this study 200 nicotine-dependent cigarette smokers will participate in an 8-week double-blind placebo-controlled trial and then will be followed over 4 years Participants will be randomly assigned to receive either selegiline or placebo Selegiline doses of 5 mg will be taken once a day during the first week This will be increased to 5 mg twice daily for the remaining 7 weeks The target smoking quit date will be Day 15 All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinics Smoke Free and Livin It program The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial Days 29-56 and 7-day point prevalence abstinence at the end of the 8-week trial Days 49-56
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 |
|---|---|---|---|
| R01DA015757 | NIH | None | None |
| R01-15757-1 | None | None | None |
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA015757 |