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

NCT07124702 | Recruiting

• 2 other identifiers: STUDY00008644UL1TR001412
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Nicotine abstinence

  Research staff who are blinded to the participant's group assignment will administer a timeline follow-back interview (trained by the PI, Dr. Wen) to assess the participant's recent smoking and vaping history. Based on self-reports, we will classify smoking and vaping status in the past 7 days (7-day point prevalence) prior to the outcome assessment visits at pre-test, 8 weeks after randomization, and at the end of pregnancy. To confirm self-reported complete nicotine abstinence (i.e., abstinence from both ECs and CCs), 5.0 mL of urine samples will be collected at study visits in the 8th week after randomization and at the end of pregnancy (approximately 35 weeks). An HPLC-MS/MS assay will be used as a gold standard test to determine urine cotinine levels.

  8 weeks after randomization, at the end of pregnancy

Secondary Outcomes (3)

• The time needed to achieve nicotine abstinence

  8 weeks after randomization, at the end of pregnancy

• The mother's gestational weight gain

  Right before delivery

• The infant's birth-weight-forgestational- age z score

  At birth

Study Arms (3)

Simultaneous cessation intervention

EXPERIMENTAL

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: Simultaneous cessation intervention

Stepwise cessation intervention

EXPERIMENTAL

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: Stepwise cessation intervention

Control group

ACTIVE COMPARATOR

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.

Behavioral: Behavior counseling only

Interventions

Simultaneous cessation 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.

Simultaneous cessation intervention

Stepwise cessation 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.

Stepwise cessation intervention

Behavior counseling only 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Less than 21 weeks pregnant to ensure adequate time for intervention;
• 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 may not qualify if:

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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Gestational Weight Gain; Tobacco Use

Condition Hierarchy (Ancestors)

Smoking; Behavior; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaozhong Wen, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaozhong Wen, PhD

CONTACT

716-829-6811; xiaozhon@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)