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

NCT ID: NCT07124702

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-03-31

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.

Detailed Description

Study overview. We propose a pilot randomized controlled trial (RCT) to develop and test a cessation program for dual users during pregnancy. We will enroll 45 Western New York pregnant mothers (≤20 weeks gestational age) with low household incomes who are currently dual-using CCs and nicotine-containing ECs. These mothers will be randomized into one of three groups: 1) simultaneous cessation intervention (N=15), 2) stepwise cessation intervention (N=15), and 3) control group (N=15). Both intervention groups will receive a multi-component intervention, including behavior counseling, biomarker feedback, and contingent financial incentives for biochemically verified abstinence. However, the two intervention groups will have different orders of cessation targets: the simultaneous cessation group will target CCs and ECs at the same time, whereas the stepwise cessation group will first target CCs and then target ECs after quitting CCs. The control group will only receive behavior counseling. Mothers will be followed throughout pregnancy until delivery. The primary outcome is nicotine abstinence at 8 weeks after randomization.

Randomization. After the pre-test visit, participants who are still dual using CCs and ECs will be randomized into one of three groups: 1) simultaneous cessation intervention group, 2) stepwise cessation intervention group, and 3) control group. A computer will be used to generate balanced-permuted blocks with a block size of 9 and a 3-3-3 ratio, which can ensure equal numbers of participants across the three groups throughout the project. The study biostatistician will create the sequences a priori and then apply them using a workflow and database software system.

Sample size. Based on the literature and our previous intervention, we estimate the dual-use nicotine abstinence rate at 8 weeks after randomization (the primary maternal outcome) to be 30% in the intervention groups versus 10% in the control group. Accordingly, we need 62 participants per group to detect a significant difference in nicotine abstinence with 80% power at a significance level of 0.05 (Aim 1). Therefore, 15 participants per group for this pilot study should provide a sufficient sample size to test study feasibility, recruitment, and retention and yield preliminary data on intervention efficacy and the magnitude of group differences in health outcomes to support an NIH R01 grant application for a large project.

Statistical analysis. We will first conduct descriptive analyses to determine if transformations are necessary, and then run bivariate analyses. We will compare the distributions of covariates above across the 3 randomized groups. Only the unbalanced covariates that predict smoking/vaping abstinence will be controlled in data analyses. We will use Intention-to-Treat analysis, i.e., including all women as assigned at randomization. Multiple imputations with 20 replicates will be used to impute missing data on outcomes or covariates.36 Sensitivity analysis will be conducted by conservatively assuming participants lost in the follow-up to be current dual users.

We will use Chi-square tests to compare categorical outcomes (e.g., maternal nicotine abstinence rates) and analysis of variance to compare continuous outcomes (e.g., infant birth-weight-for-gestational-age z-score) across groups. Then, we will use multivariable logistic and linear regression models to fit categorical and continuous outcomes, respectively. A propensity score approach will be used to control confounders, including socio-demographics, pregnancy-related characteristics, and other substance use. The model will include group assignment (simultaneous cessation intervention vs. control, stepwise cessation intervention vs. control, or simultaneous vs. stepwise cessation intervention), fidelity of intervention delivery, adherence to intervention, and a propensity score derived from all unbalanced covariates. We will estimate the group differences in nicotine abstinence rates and odds ratios from the regression model.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Simultaneous cessation intervention

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Stepwise cessation intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Behavior counseling only

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Xiaozhong Wen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaozhong Wen, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

State University of New York at Buffalo

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Xiaozhong Wen, PhD

Role: CONTACT

Phone: 716-829-6811

Email: xiaozhon@buffalo.edu

Facility Contacts

Xiaozhong Wen, PhD

Role: primary

Other Identifiers

UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008644

Identifier Type: -

Identifier Source: org_study_id