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

NCT01286402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-02-04

Study results available
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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.

Conditions

  • Smoking Cessation

Interventions

DRUG

Bupropion SR

* 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

OTHER

Placebo

-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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Gilstrap, Larry C, M.D.

    collaborator INDIV

  • The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Angela L Stotts, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-10-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286402 on ClinicalTrials.gov