NCT00006170 - Bupropion and Weight Control for Smoking Cessation - 1 | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

349

Conditions

Tobacco Use Disorder

Interventions

BupropionDRUG

smoking cessation medication aid

PlaceboDRUG

A matched placebo pill

weight concerns interventionBEHAVIORAL

cognitive behavioral treatment to address weight concners

smoking cessation intervention

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Smoking Abstinence

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.

Time frame: 3 months

Smoking Abstinence

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.

Time frame: 6 months

Smoking Abstinence

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.

Time frame: 12 months