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Nicotine Replacement for Smoking Cessation During Pregnancy

NCT01656733 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2019-09-30

Study results available
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Summary

This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).

Conditions

  • Nicotine Dependence
  • Smoking Cessation

Interventions

DRUG

Nicotrol Inhaler

Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

DRUG

Placebo Inhaler

Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • UConn Health

    lead OTHER

Principal Investigators

  • Cheryl Oncken, M.D., M.P.H. · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-09-30
Completion
2017-10-25

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 NCT01656733 on ClinicalTrials.gov