Recruiting

Cessation Program

Sponsor:

State University of New York at Buffalo

Code:

NCT07124702

Conditions

Dual Use of Cigarettes and E-cigarettes

Gestational Weight Gain

Birth-weight-for-gestational-age z Score

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Simultaneous cessation intervention

Stepwise cessation intervention

Behavior counseling only

Study Details

Brief 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

Study ID

NCT07124702

Start date

Oct 1, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Teen pregnancy (<18 y);
  • Unstable housing;
  • Uncontrolled mental health disorders;
  • Non-English speakers.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

active comparator: Control group

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.

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.

Primary outcome measure

  • Nicotine abstinence [ Time Frame: 8 weeks after randomization, at the end of pregnancy ]

Central Contacts and Locations

Central contacts

Xiaozhong Wen, PhD

716-829-6811xiaozhon@buffalo.edu

Locations

State University of New York at Buffalo

Recruiting

Buffalo, New York, United States, 14214

Contacts

Xiaozhong Wen, PhD

716-829-6811xiaozhon@buffalo.edu

Principal Investigator:

Xiaozhong Wen, PhD

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Randomized Controlled Trial
  • Tobacco use
  • Electronic cigarette
  • Pregnancy
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2025-11-13.