Stopping both cigarettes and e-cigarettes during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xiaozhon@buffalo.edu
• Phone: 716-829-6811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.