RecruitingNot ApplicableNCT07124702

Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy

Sponsor

State University of New York at Buffalo

Enrollment

45 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Gestational Weight Gain Dual Use of Cigarettes and E-cigarettes Birth-weight-for-gestational-age z Score

Summary

We propose a randomized controlled trial to develop and evaluate a cessation program with two different strategies for dual users during pregnancy. We plan to enroll 45 pregnant mothers (≤20 gestational weeks) with low household incomes from the Western NY region. To be eligible, they must be currently dual using CCs and nicotine-containing ECs. These mothers will be randomized into one of three groups: 1) simultaneous cessation intervention group (N=15), 2) stepwise cessation intervention group (N=15), and 3) control group (N=15). We hypothesize that nicotine abstinence rates at 8 weeks after randomization will be higher in the intervention groups than in the control group.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Behavior counseling only, a behavioral approach called Simultaneous cessation intervention, and others for people with birth-weight-for-gestational-age z score, dual use of cigarettes and e-cigarettes, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSimultaneous cessation intervention

This simultaneous cessation intervention group will target CCs and ECs at the same time. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.

BEHAVIORALStepwise cessation intervention

This stepwise cessation intervention group will first target CCs and then target ECs after quitting CCs. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.

BEHAVIORALBehavior counseling only

Participants assigned to the control group will receive behavior counseling only. They will complete the same number of study visits as their counterparts in the intervention groups.

Locations(1)

State University of New York at Buffalo

Buffalo, New York, United States

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NCT07124702

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