Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07124702

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

Led by State University of New York at Buffalo · Updated on 2025-11-13

45

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

S

State University of New York at Buffalo

Lead Sponsor

N

National Center for Advancing Translational Sciences (NCATS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 85% of the federal poverty level
Not Eligible

You will not qualify if you...

  • Teen pregnancy (under 18 years old)
  • Unstable housing
  • Uncontrolled mental health disorders
  • Non-English speakers

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Trial Site Locations

Total: 1 location

1

State University of New York at Buffalo

Buffalo, New York, United States, 14214

Actively Recruiting

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Research Team

X

Xiaozhong Wen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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