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Pharmacologic Intervention for Postcessation Weight Gain

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005704
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: July 2000
  Purpose

To test pharmacologic intervention for smoking postcessation weight gain using nicotine gum and phenylpropanolamine (PPA).


Condition
Cardiovascular Diseases
Heart Diseases
Obesity

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1991
Estimated Study Completion Date: June 1997
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005704     History of Changes
Other Study ID Numbers: 4359
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014