Bupropion SR Plus Counseling for Smoking Cessation

University of Wisconsin, Madison463 enrolled

Overview

The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

463

Conditions

Tobacco Dependence Smoking

Interventions

Active bupropion + counselingDRUG

Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks. Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date.

Active bupropion, No counselingDRUG

Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day. Counseling: No cessation counseling, only medication checks

Placebo medication + counselingDRUG

Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day. Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Smoke 10 or more cigarettes per day * Expired carbon monoxide (CO) level greater than 9 parts per million (ppm) * Motivated to quit smoking (score of 3 on 4-point self-report scale) * Willing to fulfill study requirements Exclusion Criteria: * Carbon monoxide breath test score below 9 ppm * Serious psychopathology (bipolar disorder, psychosis) * Center for Epidemiologic Studies Depression Scale CES-D)score over 16 * Contraindications for use of bupropion * History of seizure disorder * History of eating disorder * Current heavy drinking * Risk of pregnancy * Current breastfeeding

Locations (1)

UW Center for Tobacco Research and Intervention

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

7-day Point Prevalence Abstinence From Smoking at 6 Months

No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Time frame: 6 months

Data from ClinicalTrials.gov

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