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Bupropion and Weight Control for Smoking Cessation - 1
This study is ongoing, but not recruiting participants.
First Received: August 9, 2000   Last Updated: November 3, 2005   History of Changes
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00006170
  Purpose

The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.


Condition Intervention Phase
Tobacco Use Disorder
Behavioral: Bupropion
Phase IV

MedlinePlus related topics: Quitting Smoking Smoking
Drug Information available for: Bupropion hydrochloride Bupropion
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control
Official Title: Bupropion and Weight Control for Smoking Cessation

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment: 357
Study Start Date: September 2000
Detailed Description:

Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoke at least 10 cigarettes per day
  • Report concern about cessation-related weight gain
  • Motivated to quit smoking

Exclusion Criteria:

  • Currently pregnant, lactating, or no medically approved method of contraception
  • Major medical problem
  • History of seizure disorder or head injury
  • Current or historical psychosis or bipolar disorder
  • History of alcohol or substance abuse within previous year
  • Current or historical eating disorder
  • Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month
  • Multiple Drug Allergies
  • Current major depressive disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006170

Locations
United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213 2593
Sponsors and Collaborators
Investigators
Principal Investigator: Marsha Marcus, Ph.D. Western Psychiatric Institute & Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: NIDA-04174-1, R01-04174-1
Study First Received: August 9, 2000
Last Updated: November 3, 2005
ClinicalTrials.gov Identifier: NCT00006170     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Tobacco Use Disorder
Psychotropic Drugs
Disorders of Environmental Origin
Body Weight
Smoking
Dopamine
Mental Disorders
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Therapeutic Uses
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 06, 2009