What this study is
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.
What's being tested
- Simultaneous cessation intervention
Intervention · BEHAVIORAL
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.
- Stepwise cessation intervention
Intervention · BEHAVIORAL
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.
- Behavior counseling only
Intervention · BEHAVIORAL
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.
Study details
- Sponsor
- State University of New York at Buffalo
- Conditions
- Dual Use of Cigarettes and E-cigarettes · Gestational Weight Gain · Birth-weight-for-gestational-age z Score
- Enrolling
- 45 people
- Starts
- 2025-10-01
- Est. completion
- 2027-03-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Less than 21 weeks pregnant to ensure adequate time for intervention;
- 18 years or older;
- Actively using both cigarettes and electronic cigarettes (e-cigarettes);
- Willing to receive cessation information;
- Able to read, understand, and speak English;
- Having a low household income defined as ≤185% of the federal poverty level.
You can't join if
- Teen pregnancy (<18 y);
- Unstable housing;
- Uncontrolled mental health disorders;
- Non-English speakers.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openState University of New York at Buffalo
Buffalo, New York, United States
- Xiaozhong Wen, PhD · Contact716-829-6811xiaozhon@buffalo.edu
- Xiaozhong Wen, PhD · Principal investigator
Recruiting
Study team
Sponsor
State University of New York at Buffalo
Study ID STUDY00008644
Principal investigator
Xiaozhong Wen, PhD
State University of New York at Buffalo
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.