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

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07124702
Status
Recruiting
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Conditions

  • Birth-weight-for-gestational-age z Score
  • Dual Use of Cigarettes and E-cigarettes
  • Gestational Weight Gain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Simultaneous cessation intervention — BEHAVIORAL
    This simultaneous cessation intervention group will target CCs and ECs at the same time. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.
  • Stepwise cessation intervention — BEHAVIORAL
    This stepwise cessation intervention group will first target CCs and then target ECs after quitting CCs. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.
  • Behavior counseling only — BEHAVIORAL
    Participants assigned to the control group will receive behavior counseling only. They will complete the same number of study visits as their counterparts in the intervention groups.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Simultaneous cessation intervention
    This simultaneous cessation intervention group will target CCs and ECs at the same time. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.
  • Experimental: Stepwise cessation intervention
    This stepwise cessation intervention group will first target CCs and then target ECs after quitting CCs. Participants in this group will receive a multi-component cessation intervention, including behavior counseling, biomarker feedback via monitoring changes in levels of exposure to nicotine (urine cotinine) and CC smoke (breath carbon monoxide), and contingent financial incentives for biochemically verified abstinence.
  • Active Comparator: Control group
    Participants assigned to the control group will receive behavior counseling only. They will complete the same number of study visits as their counterparts in the intervention groups.

Primary Outcome Measure

Nicotine abstinence [ Time Frame: 8 weeks after randomization, at the end of pregnancy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
State University of New York at BuffaloBuffaloNew York14214
Xiaozhong Wen, PhD
[email protected]
716-829-6811
Xiaozhong Wen, PhD (PRINCIPAL_INVESTIGATOR)

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