Clinical trial NCT00006170: Bupropion and Weight Control for Smoking Cessation - 1
Official title: Bupropion and Weight Control for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Disorder
Keywords: smoking cessation
Women
bupropion
weight concerns
weight
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2000-08-10
Enrollment: 349
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 3 months
measure: Smoking Abstinence
timeFrame: 6 months
measure: Smoking Abstinence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute & Clinic
state: Pennsylvania
Study officials:
affiliation: Western Psychiatric Institute & Clinic
name: Marsha Marcus, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.