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Bupropion and Weight Control for Smoking Cessation - 1

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ClinicalTrials.gov Identifier: NCT00006170
Recruitment Status : Completed
First Posted : August 10, 2000
Results First Posted : November 14, 2013
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marsha Marcus, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Bupropion Drug: Placebo Behavioral: weight concerns intervention Behavioral: smoking cessation intervention Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion and Weight Control for Smoking Cessation
Study Start Date : September 2000
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupropion and Weight Concerns intervention
Bupropion SR and a weight concerns psychosocial intervention
Drug: Bupropion
smoking cessation medication aid
Other Name: zyban

Behavioral: weight concerns intervention
cognitive behavioral treatment to address weight concners

Active Comparator: Placebo and Weight Concerns
A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
Drug: Placebo
A matched placebo pill

Behavioral: weight concerns intervention
cognitive behavioral treatment to address weight concners

Active Comparator: Bupropion and standard smoking cessation
Bupropion SR and a time and attention controlled smoking cessation intervention
Drug: Bupropion
smoking cessation medication aid
Other Name: zyban

Behavioral: smoking cessation intervention
Cognitive behavioral intervention for smoking cessation

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

Behavioral: smoking cessation intervention
Cognitive behavioral intervention for smoking cessation




Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 3 months ]
    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.

  2. Smoking Abstinence [ Time Frame: 6 months ]
    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.

  3. Smoking Abstinence [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2000    Key Record Dates
Results First Posted: November 14, 2013
Last Update Posted: July 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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