Cessation Interventions for Dual Use of Cigarettes and E-Cigarettes During Pregnancy

Overseen By Xiaozhong Wen, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Teen pregnancy, Unstable housing, Mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women who use both cigarettes and e-cigarettes quit smoking. It tests two quitting strategies: one where participants quit both simultaneously (simultaneous cessation intervention) and another where they quit cigarettes first, then e-cigarettes (stepwise cessation intervention). The goal is to determine which approach helps more women remain smoke-free eight weeks after starting the program. Participants should be less than 21 weeks pregnant, use both cigarettes and e-cigarettes, and have a low household income. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that may improve smoking cessation strategies for pregnant women.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using e-cigarettes during pregnancy is about as safe as using nicotine patches and might help women quit smoking. However, vaping while pregnant carries risks. Some studies have found poor birth outcomes and a higher risk of fetal death with certain e-cigarette flavors.

Reports suggest that pregnant women using e-cigarettes may have higher success rates in quitting smoking step-by-step. Still, the safety of e-cigarettes during pregnancy remains unclear. Non-drug methods, like counseling, are usually the safest and most effective way to quit smoking when pregnant.

These studies have produced mixed results. While there might be benefits, there are also possible risks. Always consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cessation interventions for pregnant women using both cigarettes and e-cigarettes because they offer a tailored approach that goes beyond standard behavior counseling. The simultaneous cessation intervention uniquely targets both cigarette and e-cigarette use at the same time, offering participants comprehensive support through behavior counseling, biomarker feedback, and financial incentives for verified abstinence. On the other hand, the stepwise cessation intervention focuses first on quitting cigarettes before tackling e-cigarettes, providing a structured and phased approach. These methods are innovative because they incorporate real-time feedback on nicotine exposure and smoke, potentially enhancing motivation and success rates compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for dual use of cigarettes and e-cigarettes during pregnancy?

Research has shown that e-cigarettes might help pregnant smokers quit more effectively than nicotine patches. In this trial, participants will join different treatment arms to evaluate cessation strategies. The simultaneous cessation intervention, where both cigarettes and e-cigarettes are quit together, has shown promise in increasing success rates during pregnancy. In contrast, the stepwise cessation intervention, where cigarettes are quit first and then e-cigarettes, appears less effective. Behavioral support can assist, but the success of the stepwise method varies. Overall, quitting both simultaneously seems more effective for pregnant women trying to stop smoking both cigarettes and e-cigarettes. ^{3 6 7 8 9}

Who Is on the Research Team?

Xiaozhong Wen, PhD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for pregnant mothers within 20 weeks of gestation, with low household incomes from Western NY who currently use both cigarettes and e-cigarettes. Participants must be dual users to qualify.

Inclusion Criteria

Less than 21 weeks pregnant to ensure adequate time for intervention

Actively using both cigarettes and electronic cigarettes (e-cigarettes)

I am open to receiving information on how to quit.

Exclusion Criteria

Unstable housing

Non-English speakers

Uncontrolled mental health disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Pre-test

Participants are randomized into one of three groups and complete a pre-test visit

1 week

1 visit (in-person)

Treatment

Participants receive behavior counseling, biomarker feedback, and contingent financial incentives for biochemically verified abstinence

8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for nicotine abstinence and other health outcomes until delivery

Until delivery (approximately 35 weeks)

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests two cessation strategies against a control group receiving only behavior counseling. One group will try stopping all nicotine products at once, while another will quit step by step.

How Is the Trial Designed?

Group I: Stepwise cessation intervention Experimental Treatment 1 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.

Group II: Simultaneous cessation intervention Experimental Treatment 1 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.

Group III: Control group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10599072/

Helping pregnant smokers quit: a multi-centre randomised ... In pregnant smokers seeking help, compared to nicotine patches, e-cigarettes are probably more effective, do not pose more risks to birth outcomes assessed in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06027840

Concurrent vs. Sequential Cessation of Dual Cigarette and ... The purpose of this research study is to understand whether concurrent treatment for cigarettes and e-cigarettes in which an individual quits both products ...

3. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-7299-7

E-cigarettes and smoking cessation: a prospective study of a ... At baseline, 74 (17.29%) pregnant smokers used e-cigarettes in the past 30 days and 36 (8.41%) used e-cigarettes in the past 7 days. The primary ...

4. nature.com nature.com/articles/s41591-022-01808-0

Electronic cigarettes versus nicotine patches for smoking ... E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624014455

Examining e-cigarettes as a smoking cessation treatment Our analysis indicated that e-cigarettes are more effective than other treatments for smoking cessation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9888444/

E-cigarette use during pregnancy and its association with ... Pregnant women who vaped mint-/menthol-flavored e-cigarettes during pregnancy showed elevated risk of experiencing fetal death than those who vaped other ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06633-6

Vaping during pregnancy: a systematic review of health ... Smoking during pregnancy is harmful to maternal, fetal and child health; increases the risk of adverse birth outcomes such as preterm birth, low ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0306460324000546

Smoking cessation in pregnant women: A randomized ... Prenatal smoking and stress are associated with adverse health effects for women themselves and are risk factors for adverse outcomes of the child.

9. link.springer.com link.springer.com/article/10.1186/s12982-024-00301-y

Insights into the global landscape of e-cigarette utilization ... E-cigarette use by mothers during pregnancy has been linked to poor birth outcomes. ... E-cigarette use for smoking cessation in pregnancy ...