Smoking Reduction In Gravid Substance Use Disorders

NCT04132232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-08-05

Study results available
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Summary

The aim of this study is to encourage smoking cessation in women with substance use disorders by providing knowledge of expired carbon monoxide. We hypothesize that women who are provided knowledge of their expired carbon monoxide and the associated percent fetal carboxyhemoglobin will have a greater success at quitting smoking during pregnancy than women who are not provided this information.

A secondary aim of the study is to correlate expired carbon monoxide throughout pregnancy with infant birth weight.

Conditions

  • Tobacco Smoking in Mother Complicating Pregnancy
  • Tobacco Use Disorder
  • Tobacco Smoking

Interventions

DIAGNOSTIC_TEST

knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels

Will use the Smokerlyzer® device at each visit and be provided information on exhaled carbon monoxide and fetal carboxyhemoglobin. Risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin level will be provided.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Rachel G Sinkey, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2023-12-01
Completion
2023-12-01

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 NCT04132232 on ClinicalTrials.gov