Bupropion SR Plus Counseling for Smoking Cessation

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Tobacco Dependence; Smoking

Treatments: Drug: Active bupropion + counseling; Drug: Placebo medication + counseling; Drug: Placebo medication, No counseling; Drug: Active bupropion, No counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01621009

P50CA084724 (U.S. NIH Grant/Contract)

P50DA019706 (U.S. NIH Grant/Contract)

1998-369

Details and patient eligibility

About

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.

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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463 participants in 4 patient groups, including a placebo group

Active bupropion + counseling

Active Comparator group

Description:

Active bupropion SR plus eight 10-minute individual counseling sessions.

Treatment:

Drug: Active bupropion + counseling

Active bupropion , No counseling

Active Comparator group

Description:

Active bupropion, No counseling, only medication checks

Treatment:

Drug: Active bupropion, No counseling

Placebo medication + counseling

Placebo Comparator group

Description:

Placebo bupropion plus eight 10-minute individual counseling sessions

Treatment:

Drug: Placebo medication + counseling

Placebo medication, No counseling

Placebo Comparator group

Description:

Placebo bupropion, No counseling, just medication checks

Treatment:

Drug: Placebo medication, No counseling