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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorState University of New York at Buffalo

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

Sponsors and collaborators

State University of New York at Buffalo

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator