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

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.

NCT Number	NCT07124702
Lead Sponsor	State University of New York at Buffalo Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions	Dual Use of Cigarettes and E-cigarettes, Gestational Weight Gain, Birth-weight-for-gestational-age z Score
Enrollment	45 participants
Start Date	2025-10-01
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-13