Bupropion and Weight Control for Smoking Cessation - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marsha Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00006170
First received: August 9, 2000
Last updated: November 18, 2013
Last verified: November 2013
  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
Drug: Bupropion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion and Weight Control for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.

  • Smoking Abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.

  • Smoking Abstinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.


Enrollment: 349
Study Start Date: September 2000
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buproion
Bupropion SR
Drug: Bupropion
Placebo Comparator: placebo

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
University of Pittsburgh
Investigators
Principal Investigator: Marsha Marcus, Ph.D. Western Psychiatric Institute & Clinic
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marsha Marcus, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00006170     History of Changes
Other Study ID Numbers: NIDA-04174-1, R01DA004174, R01-04174-1
Study First Received: August 9, 2000
Results First Received: June 18, 2013
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 20, 2014