Bupropion and Weight Control for Smoking Cessation - 1

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marsha Marcus, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00006170
First received: August 9, 2000
Last updated: February 3, 2016
Last verified: January 2016
  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
Drug: Placebo
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: Bupropion and Weight Control
Bupropion SR and a weight concerns psychosocial intervention
Drug: Bupropion
Active Comparator: Placebo and Weight Control
A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
Drug: Placebo
A matched placebo pill
Active Comparator: Bupropion and standard smoking cessation
Bupropion SR and a time and attention controlled smoking cessation intervention
Drug: Bupropion
Placebo Comparator: Placebo and standard smoking cessation
A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
Drug: Placebo
A matched placebo pill

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Marsha Marcus, Ph.D. Western Psychiatric Institute & Clinic
  More Information

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  R0104174 
Study First Received: August 9, 2000
Results First Received: June 18, 2013
Last Updated: February 3, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
smoking cessation
Women
bupropion
weight concerns
weight

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 26, 2016