CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 463 enrolled
Drug / intervention
Active bupropion + counseling +3 moredrug
Likely dose
Active bupropion + counseling 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01621009
NCT01621009Phase 4Completed

A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling

University of Wisconsin, Madison·interventional·Posted Jun 15, 2012·Updated Jan 27, 2016

In Brief

A Phase 4 clinical trial evaluating Active bupropion + counseling, Active bupropion, No counseling, and 2 other interventions for Tobacco Dependence and Smoking. Completed, enrolled 463 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2012
Enrollment StartJan 1, 2001
Primary CompletionOct 1, 2002
Study CompletionOct 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.0 years ago

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.

Placebo medication, No counselingdrug

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