About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Teen pregnancy (<18 y);

Unstable housing;

Uncontrolled mental health disorders;

Non-English speakers.

Trial design

Treatments tested in this trial

  • Simultaneous cessation intervention
  • Stepwise cessation intervention
  • Behavior counseling only

Treatment groups

45 Participants
are divided into 3 treatment groups

Locations

1
State University of New York at Buffalo14214, BuffaloNew York, United States

Sponsors and collaborators

State University of New York at Buffalo

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator