Actively Recruiting
Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy
Led by State University of New York at Buffalo · Updated on 2025-11-13
45
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
State University of New York at Buffalo
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to develop and test a cessation program for pregnant women who currently use both cigarettes and nicotine-containing e-cigarettes. The study focuses on 45 pregnant mothers at 20 weeks gestation or less, with low household incomes, to evaluate two different strategies for quitting both products during pregnancy. The main goal is to determine if these interventions can increase nicotine abstinence rates compared to a control group. Participants will be randomly assigned to one of three groups: simultaneous cessation intervention, stepwise cessation intervention, or control. The simultaneous group will target quitting cigarettes and e-cigarettes at the same time, while the stepwise group will first quit cigarettes and then e-cigarettes. Both intervention groups receive behavior counseling, biomarker feedback through urine cotinine and breath carbon monoxide monitoring, and financial incentives for verified abstinence. The control group receives behavior counseling only but completes the same number of study visits. Throughout the pregnancy until delivery, mothers will be followed with regular visits to monitor progress. Assessments include nicotine abstinence at 8 weeks after randomization, the time needed to achieve abstinence, gestational weight gain, and infant birth weight adjusted for gestational age. Researchers will use statistical analyses to compare outcomes across groups, controlling for various factors. The total participation duration covers pregnancy through delivery, with close monitoring of intervention adherence and verified abstinence.
CONDITIONS
Brief Title
Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women less than 21 weeks gestation to allow enough time for intervention
- Age 18 years or older
- Currently using both cigarettes and nicotine-containing e-cigarettes
- Willing to receive cessation information
- Able to read, understand, and speak English
- Have a low household income defined as at or below 185% of the federal poverty level
You will not qualify if you...
- Teen pregnancy under 18 years of age
- Unstable housing situation
- Uncontrolled mental health disorders
- Non-English speakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until delivery (up to approximately 20 weeks depending on gestational age at enrollment)
Participants receive one of three cessation programs during pregnancy: simultaneous cessation, stepwise cessation, or behavior counseling only. Interventions include behavior counseling, biomarker feedback, and financial incentives for abstinence depending on group assignment.
Multiple visits throughout pregnancy for intervention and monitoring
Trial Site Locations
Total: 1 location
1
State University of New York at Buffalo
Buffalo, New York, United States, 14214
Actively Recruiting
Research Team
X
Xiaozhong Wen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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