Stopping both cigarettes and e-cigarettes during pregnancy

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

This project tests two different programs to help pregnant people who both smoke cigarettes and use e-cigarettes quit nicotine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: State University of New York at Buffalo (Academic / other)
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT07124702 on ClinicalTrials.gov

What this trial studies

This pilot randomized trial will enroll 45 low-income pregnant people (≤20 weeks gestation) in Western New York and randomize them equally to one of three groups: simultaneous cessation, stepwise cessation, or behavioral counseling only. Both intervention groups receive behavioral counseling, biomarker feedback, and contingent financial incentives for biochemically verified abstinence, with the simultaneous arm targeting both products at once and the stepwise arm targeting cigarettes first then e-cigarettes. The control group receives counseling only. Participants will be followed through delivery and the primary outcome is nicotine abstinence at 8 weeks after randomization.

Who should consider this trial

Good fit: Ideal candidates are pregnant people ≤20 weeks gestation who are ≥18 years old, currently use both cigarettes and nicotine-containing e-cigarettes, meet the low-income threshold, and can read and speak English.

Not a fit: People who are not dual users, are under 18, have unstable housing, uncontrolled mental health disorders, or cannot attend Buffalo-area visits are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could help pregnant people quit both cigarettes and e-cigarettes and reduce fetal nicotine exposure.

How similar studies have performed: Behavioral counseling with biomarker feedback and financial incentives has helped pregnant smokers quit cigarettes in prior research, but applying these methods specifically to simultaneous dual use of cigarettes and e-cigarettes is relatively novel.

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.

Where this trial is running

Buffalo, New York

• State University of New York at Buffalo — Buffalo, New York, United States (Recruiting)

Study contacts

• Principal investigator: Xiaozhong Wen, PhD — State University of New York at Buffalo
• Study coordinator: Xiaozhong Wen, PhD

Conditions Dual Use of Cigarettes and E-cigarettes; Gestational Weight Gain; Birth-weight-for-gestational-age z Score; Randomized Controlled Trial; Tobacco use; Electronic cigarette; Pregnancy; Intervention