Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy
State University of New York at Buffalo
Summary
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.
Description
Study overview. We propose a pilot randomized controlled trial (RCT) to develop and test a cessation program for dual users during pregnancy. We will enroll 45 Western New York pregnant mothers (≤20 weeks gestational age) with low household incomes who are currently dual-using CCs and nicotine-containing ECs. These mothers will be randomized into one of three groups: 1) simultaneous cessation intervention (N=15), 2) stepwise cessation intervention (N=15), and 3) control group (N=15). Both intervention groups will receive a multi-component intervention, including behavior counseling, biomarker…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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.
Interventions
- BehavioralSimultaneous 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.
- BehavioralStepwise 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.
- BehavioralBehavior counseling only
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.
Location
- State University of New York at BuffaloBuffalo, New York