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Bupropion for Smoking Cessation During Pregnancy

NCT01390246 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-06-07

Study results available
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Summary

This is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Conditions

  • Pregnancy Related
  • Tobacco Use Disorder

Interventions

DRUG

Bupropion SR

Bupropion SR 150 mg tablet

BEHAVIORAL

Smoking Cessation Counseling

35-min counseling by trained research nurse

DRUG

Placebo

Matching Bupropion SR placebo tablet

Sponsors & Collaborators

  • UConn Health

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Gary DV Hankins, MD · University of Texas Medical Branch at Galveston

  • Tatiana Nanovskaya, PhD · University of Texas Medical Branch at Galveston

  • Cheryl Onken, MD, MPH · UConn Health

  • Mahmoud Ahmed, PhD · University of Texas Medical Branch at Galveston

  • Shannon Clark, MD · University of Texas Medical Branch at Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01390246 on ClinicalTrials.gov