Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105482
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2005-03-14
Brief Title:
Targeted Interventions for Weight-Concerned Smokers
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Weight gain after quitting smoking is an important barrier to treatment for many smokers This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain
Detailed Description:
This is a 6-month randomized double-blind placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study which they begin on their quit date Naltrexone study medication will be started a week before their quit date and continued through the six-month period Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks bi-weekly for a month and every four weeks thereafter A follow-up appointment is completed at 12 months after participants quit date
The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent not even a puff
Secondary outcomes include an examination of alcohol consumption evaluation of urges other measures of smoking cessation success point prevalence abstinence at 12 months and food preferences A number of tertiary measures will be obtained for examining predictors of smoking cessation weight gain and naltrexone response
The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent not even a puff
Secondary outcomes include an examination of alcohol consumption evaluation of urges other measures of smoking cessation success point prevalence abstinence at 12 months and food preferences A number of tertiary measures will be obtained for examining predictors of smoking cessation weight gain and naltrexone response
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 |
|---|---|---|---|
| 9P50AA015632 | NIH | None | httpsreporternihgovquickSearch9P50AA015632 |
| P50AA015632 | NIH | None | None |