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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Bupropion; Behavioral: weight concerns intervention; Drug: Placebo; Behavioral: smoking cessation intervention

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
• Enrollment (Actual): 349
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213 2593
      • Western Psychiatric Institute & Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupropion and Weight Concerns intervention; Bupropion SR and a weight concerns psychosocial intervention	Drug: Bupropion; smoking cessation medication aid; Other Names: 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	Behavioral: weight concerns intervention; cognitive behavioral treatment to address weight concners; 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; smoking cessation medication aid; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Marsha Marcus, Ph.D., Western Psychiatric Institute & Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: August 9, 2000
• First Submitted That Met QC Criteria: August 9, 2000
• First Posted (Estimate): August 10, 2000

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: June 22, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Women; smoking cessation; bupropion; weight; weight concerns
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: NIDA-04174-1; R01DA004174 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO