Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129246
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2005-08-09
Brief Title:
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Naltrexone Bupropion to Stop Smoking With Less Weight Gain
Status:
COMPLETED
Status Verified Date:
2020-11
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 test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain
Detailed Description:
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release SR in six male and fourteen female participants This pilot study is being conducted to determine
effect size estimates for smoking cessation and post-cessation weight gain which will be used to compute the sample size needed for a large-scale clinical trial and
compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR In addition to examining the sample in this study the investigators plan to compare this sample to a sample of matched controls
effect size estimates for smoking cessation and post-cessation weight gain which will be used to compute the sample size needed for a large-scale clinical trial and
compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR In addition to examining the sample in this study the investigators plan to compare this sample to a sample of matched controls
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 |
|---|---|---|---|
| NIH Grant 9 P50-AA15632 | US NIH GrantContract | None | httpsreporternihgovquickSearchP50AA015632 |
| P50AA015632 | NIH | None | None |