CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Bupropion SR +1 moredrug
Likely dose
Bupropion SR 150mgfrom 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/NCT01286402
NCT01286402Phase 2Completed
CompareCT.gov

Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

The University of Texas Health Science Center, Houston·interventional·Posted Jan 31, 2011·Updated Feb 4, 2016

In Brief

A Phase 2 clinical trial evaluating Bupropion SR and Placebo for Smoking Cessation. Completed, enrolled 11 participants across 1 site.

Detailed Summary

This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
CollaboratorsM.D. Anderson Cancer Center, Gilstrap, Larry C, M.D., The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2011
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.4 years ago

Interventions

Bupropion SRdrug

* 150mg, taken orally, taken daily for the 1st 3 days * 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment

Placeboother

-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment