CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 646 enrolled
Drug / intervention
Bupropion +3 moredrug
Likely dose
Bupropion 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/NCT00507728
NCT00507728Phase 3Completed

Pharmacogenetics, Emotional Reactivity and Smoking

M.D. Anderson Cancer Center·interventional·Posted Jul 26, 2007·Updated May 6, 2021

In Brief

A Phase 3 clinical trial evaluating Bupropion, Varenicline, and 2 other interventions for Tobacco Use Disorder and Smoking Cessation. Completed, enrolled 646 participants across 1 site.

Detailed Summary

The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 26, 2007
Enrollment StartDec 8, 2005
Primary CompletionDec 18, 2019
TodayJul 2, 2026
Enrollment to primary: 14.0 yearsPosted 18.9 years ago

Interventions

Bupropiondrug

Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)

Vareniclinedrug

Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)

Placebodrug

Placebo by mouth for 12 weeks.

Smoking Cessation Counselingbehavioral

Counseling over 8 months and telephone support calls.