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

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.

Conditions

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• State University of New York at Buffalo

  lead OTHER

Principal Investigators

• Xiaozhong Wen, PhD · State University of New York at Buffalo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-09-30

Completion

2027-03-31

Countries

• United States

Study Locations