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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: June 22, 2016
Last verified: June 2016

August 9, 2000
June 22, 2016
September 2000
December 2009   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00006170 on ClinicalTrials.gov Archive Site
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Bupropion and Weight Control for Smoking Cessation - 1
Bupropion and Weight Control for Smoking Cessation
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Use Disorder
  • Drug: Bupropion
    smoking cessation medication aid
    Other Name: zyban
  • Drug: Placebo
    A matched placebo pill
  • Behavioral: weight concerns intervention
    cognitive behavioral treatment to address weight concners
  • Behavioral: smoking cessation intervention
    Cognitive behavioral intervention for smoking cessation
  • Experimental: Bupropion and Weight Concerns intervention
    Bupropion SR and a weight concerns psychosocial intervention
    Interventions:
    • Drug: Bupropion
    • Behavioral: weight concerns intervention
  • Active Comparator: Placebo and Weight Concerns
    A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
    Interventions:
    • Drug: Placebo
    • Behavioral: weight concerns intervention
  • Active Comparator: Bupropion and standard smoking cessation
    Bupropion SR and a time and attention controlled smoking cessation intervention
    Interventions:
    • Drug: Bupropion
    • Behavioral: smoking cessation intervention
  • 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
    Interventions:
    • Drug: Placebo
    • Behavioral: smoking cessation intervention
Levine MD, Perkins KA, Kalarchian MA, Cheng Y, Houck PR, Slane JD, Marcus MD. Bupropion and cognitive behavioral therapy for weight-concerned women smokers. Arch Intern Med. 2010 Mar 22;170(6):543-50. doi: 10.1001/archinternmed.2010.33.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
349
September 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006170
NIDA-04174-1, R01DA004174
No
No
Not Provided
Marsha Marcus, University of Pittsburgh
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Principal Investigator: Marsha Marcus, Ph.D. Western Psychiatric Institute & Clinic
University of Pittsburgh
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP