Bupropion SR Plus Counseling for Smoking Cessation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tobacco Dependence Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Active bupropion + counseling

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

Group Type ACTIVE_COMPARATOR

Active bupropion + counseling

Intervention Type DRUG

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 counseling

Active bupropion, No counseling, only medication checks

Group Type ACTIVE_COMPARATOR

Active bupropion, No counseling

Intervention Type DRUG

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 + counseling

Placebo bupropion plus eight 10-minute individual counseling sessions

Group Type PLACEBO_COMPARATOR

Placebo medication + counseling

Intervention Type DRUG

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.

Placebo medication, No counseling

Placebo bupropion, No counseling, just medication checks

Group Type PLACEBO_COMPARATOR

Placebo medication, No counseling

Intervention Type DRUG

Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.

Counseling: No counseling, just medication checks

Interventions

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Active bupropion + counseling

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.

Intervention Type DRUG

Active bupropion, No counseling

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

Intervention Type DRUG

Placebo medication + counseling

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.

Intervention Type DRUG

Placebo medication, No counseling

Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.

Counseling: No counseling, just medication checks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes