Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502216
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2007-07-13
Brief Title:
Naltrexone and Varenicline Weight Gain and Tolerability in Cigarette Smokers
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Naltrexone and Varenicline Weight Gain and Tolerability in Smokers
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The purpose of this study is to determine whether the combination of naltrexone Depade and varenicline Chantix minimizes post-smoking cessation weight gain and how well the combination is tolerated
Detailed Description:
Varenicline a medication recently approved by the FDA results in smoking cessation rates as high as 50 significantly better than bupropion or placebo However varenicline does not reduce post-cessation weight gain so weight concerns may keep some smokers from taking advantage of this effective therapy
A potential solution would be to combine varenicline with an agent that reduces weight gain In this regard several studies have shown that naltrexone reduces weight gain OMalley et al 2006 Toll et al 2007
This effect appears to be dose dependent favoring lower doses ie 25 mg daily Thus the proposed study seeks to conduct a pilot clinical trial of low dose naltrexone 25 mg daily compared to placebo for minimizing weight gain in combination with varenicline for smoking cessation Forty individuals who smoke at least 10 cigarettes per day will receive open-label varenicline for 12 weeks according to the recommended titration schedule up to 1 mg varenicline twice daily Subjects will be randomized to receive either placebo or 25 mg naltrexone daily with treatment starting at the quit date after 1 week on varenicline to minimize nausea a side effect of both varenicline and naltrexone and continuing for 11 weeks Subjects will take 125 mg naltrexone daily for the first week and 25 mg naltrexone daily for the next 10 weeks of treatment In an effort to uncover mechanisms for naltrexones weight suppressant effects an experiment will be conducted using food odors and food consumption to examine naltrexones effects on palatability incentive value and alliesthesia
This experiment will be conducted pretreatment and after 2 weeks on naltrexone The primary aim of this pilot study is to examine weight gain in participants who complete the clinical trial treatment Weight gain for those who are continuously abstinent for the last 4 weeks of treatment and rates of adverse events will be secondary outcomes The effects of naltrexone on odorfood palatability incentive value and alliesthesia will be exploratory outcomes Effect size estimates for weight gain will be generated for a NIH grant application
A potential solution would be to combine varenicline with an agent that reduces weight gain In this regard several studies have shown that naltrexone reduces weight gain OMalley et al 2006 Toll et al 2007
This effect appears to be dose dependent favoring lower doses ie 25 mg daily Thus the proposed study seeks to conduct a pilot clinical trial of low dose naltrexone 25 mg daily compared to placebo for minimizing weight gain in combination with varenicline for smoking cessation Forty individuals who smoke at least 10 cigarettes per day will receive open-label varenicline for 12 weeks according to the recommended titration schedule up to 1 mg varenicline twice daily Subjects will be randomized to receive either placebo or 25 mg naltrexone daily with treatment starting at the quit date after 1 week on varenicline to minimize nausea a side effect of both varenicline and naltrexone and continuing for 11 weeks Subjects will take 125 mg naltrexone daily for the first week and 25 mg naltrexone daily for the next 10 weeks of treatment In an effort to uncover mechanisms for naltrexones weight suppressant effects an experiment will be conducted using food odors and food consumption to examine naltrexones effects on palatability incentive value and alliesthesia
This experiment will be conducted pretreatment and after 2 weeks on naltrexone The primary aim of this pilot study is to examine weight gain in participants who complete the clinical trial treatment Weight gain for those who are continuously abstinent for the last 4 weeks of treatment and rates of adverse events will be secondary outcomes The effects of naltrexone on odorfood palatability incentive value and alliesthesia will be exploratory outcomes Effect size estimates for weight gain will be generated for a NIH grant application
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 K12-DA00167 | US NIH GrantContract | None | httpsreporternihgovquickSearchP50AA015632 |
| P50AA015632 | NIH | None | None |
| NIH Grant P50-AA15632 | None | None | None |