Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005704
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2000-05-25
Brief Title:
Pharmacologic Intervention for Postcessation Weight Gain
Sponsor:
University of Memphis
Organization:
University of Memphis
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
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:
To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum and phenylpropanolamine PPA
Detailed Description:
BACKGROUND
Despite the potential importance of weight gain to smoking relapse in 1991 there had been virtually no success in eliminating or even reducing the weight gain following smoking cessation Two promising pharmacologic methods for reducing postcessation weight gain were nicotine gum and an over-the-counter drug phenylpropanolamine gum PPA However the relative efficacy of these two drugs had never been evaluated and the mechanisms of action of both drugs on weight gain were unknown
DESIGN NARRATIVE
The investigators determined the efficacy of nicotine gum and phenylpropanolamine PPA gum relative to a placebo in the reduction of postcessation weight gain throughout a 13-week combined behavioral and pharmacologic treatment program Following cessation of the drugs at the end of treatment they monitored long-term effects of these drugs on body weight at both a 6- and a 12-month follow-up They also determined the mechanism of action of both nicotine gum and PPA gum viz changes in dietary intake physical activity or metabolic rate on change in weight during the course of treatment and evaluated withdrawal symptoms of smoking cessation as they were moderated by either nicotine gum or PPA gum use during the course of treatment Finally they investigated whether PPA and nicotine gum produced an incremental effect on smoking cessation relative to placebo gum in a sample of female smokers who were at high risk for postcessation weight gain at posttest and at a 6- and 12-month follow-up
Despite the potential importance of weight gain to smoking relapse in 1991 there had been virtually no success in eliminating or even reducing the weight gain following smoking cessation Two promising pharmacologic methods for reducing postcessation weight gain were nicotine gum and an over-the-counter drug phenylpropanolamine gum PPA However the relative efficacy of these two drugs had never been evaluated and the mechanisms of action of both drugs on weight gain were unknown
DESIGN NARRATIVE
The investigators determined the efficacy of nicotine gum and phenylpropanolamine PPA gum relative to a placebo in the reduction of postcessation weight gain throughout a 13-week combined behavioral and pharmacologic treatment program Following cessation of the drugs at the end of treatment they monitored long-term effects of these drugs on body weight at both a 6- and a 12-month follow-up They also determined the mechanism of action of both nicotine gum and PPA gum viz changes in dietary intake physical activity or metabolic rate on change in weight during the course of treatment and evaluated withdrawal symptoms of smoking cessation as they were moderated by either nicotine gum or PPA gum use during the course of treatment Finally they investigated whether PPA and nicotine gum produced an incremental effect on smoking cessation relative to placebo gum in a sample of female smokers who were at high risk for postcessation weight gain at posttest and at a 6- and 12-month follow-up
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R18HL045057 | NIH | None | httpsreporternihgovquickSearchR18HL045057 |