Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy
Sponsor: State University of New York at Buffalo
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-10-01
Completion Date
2027-03-31
Last Updated
2025-11-13
Healthy Volunteers
No
Conditions
Interventions
Simultaneous 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.
Stepwise 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.
Behavior 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