N/A N=74 Randomized Single-blind Treatment

Smoking Reduction In Gravid Substance Use Disorders

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

Bottom Line

View on ClinicalTrials.gov: NCT04132232 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level — 22; 16 participants — p=0.06

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels (Diagnostic_test)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level	22; 16	0.06

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.

Eligibility Criteria

Inclusion Criteria

i. Age 16-45

ii. Singleton gestation

iii. Gestational age at enrollment <24 weeks

iv. Substance use disorder defined as modified National Institute on Drug Abuse ASSIST ≥4

v. Cigarette smoker using ≥10 cigarettes/day interested in quitting

Exclusion criteria

i. Known or suspected fetal growth restriction at enrollment

ii. Known fetal anomaly, aneuploidy, or demise

iii. Not interested in smoking cessation or reduction during pregnancy

iv. E-cigarette use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04132232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.