Smoking Cessation Interventions for Pregnant Women

Recruiting in Palo Alto (17 mi)

Overseen by Jan Blalock

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-Texas residence, Non-smoker, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial seeks to increase access to smoking cessation services to low-income pregnant women. Smoking is associated with an increased risk of developing cancer. Smoking during pregnancy smoking is associated with an increased risk of low birth weight, a condition that is associated with neonatal, perinatal, and infant morbidity and mortality. The overall goal of this trial is to help patients make healthy choices and provide support during pregnancy and in the first few months after the birth of the baby.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation for pregnant women, so it's best to discuss your medications with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment for smoking cessation interventions for pregnant women?

Episodic future thinking (EFT), a part of the treatment, has shown promising results in reducing cigarette demand and impulsive choices in experimental settings, which can help in smoking cessation. ^{1 2 3 4 5}

Is the smoking cessation intervention safe for pregnant women?

The research does not provide specific safety data for smoking cessation interventions in pregnant women, but episodic future thinking (EFT) has been studied in other populations without reported safety concerns. ^{3 4 5 6 7}

How is the Smoking Cessation Intervention for pregnant women different from other treatments?

This treatment is unique because it combines episodic future thinking (imagining future scenarios) with counseling and support tailored specifically for pregnant women, focusing on non-drug methods like stress management and behavioral feedback, which are safer during pregnancy compared to standard nicotine replacement therapies. ^{8 9 10 11 12}

Research Team

Jan Blalock

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for low-income pregnant women in Northeast Texas who smoke or allow smoking at home. It's also open to household members who smoke. Participants must be receiving services from WIC or FQHC clinics, consent to surveys, and speak English or Spanish.

Inclusion Criteria

PRE-TEST SURVEY FOR PREGNANT WOMEN: Consent to take surveys

I live with a pregnant woman and speak English or Spanish.

I am not pregnant and I speak English or Spanish.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telephone counseling sessions and use the Wellness app for smoking cessation and relapse prevention

Prenatal period and up to 4 months postpartum

6 sessions (prenatal), 4-6 sessions (postpartum)

Smoke-Free Homes Intervention

Participants receive the Smoke-Free Homes kit and coaching to establish a smoke-free home environment

6 weeks

3 mailings, 1 coaching call

Follow-up

Participants are monitored for effectiveness of smoking cessation and smoke-free home interventions

3 months

Treatment Details

Interventions

• Media Intervention (Behavioral Intervention)
• Smoking Cessation Intervention (Behavioral Intervention)
• Telephone-Based Intervention (Behavioral Intervention)
• Tobacco Cessation Counseling (Behavioral Intervention)

Trial Overview The study tests a program designed to help pregnant women quit smoking through counseling, telephone support, educational materials, and surveys. The goal is to reduce cancer risks associated with smoking and improve birth outcomes.

Participant Groups

Group I: Goal 4 (counseling) Experimental Treatment 4 Interventions

Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.

Group II: Goal 3 (Smoke-free Homes) Experimental Treatment 5 Interventions

Participants receive the Smoke-Free Homes kit providing guidance for how to talk with household members and visitors about not smoking inside the home. Participants may also receive 3 separate Smoke-Free Homes mailings over 6 weeks, and a coaching call from a Baby Steps for Health counselor to help follow the steps described in the mailed materials in order to set up a smoke-free home.

Group III: Goal 2 (counseling, Wellness app, self-help) Experimental Treatment 6 Interventions

Participants receive telephone counseling sessions over 30-45 minutes for a minimum of 6 sessions in the prenatal period and about 4-6 postpartum period. Participants who start counseling after birth, may receive 6-8 sessions up to 4 months postpartum. Participants may also use the Pregnancy and Wellness smartphone app that provides wellness messages, smoking cessation information, relapse prevention tips, and tips to create a smoke-free home. Participants also receive tobacco cessation self-help materials including National Partnership for Smoke Free Families and Forever Free Baby and Me.

Group IV: Goal 1 (Wellness app) Experimental Treatment 4 Interventions

Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Clinicians play a crucial role in identifying tobacco use and implementing effective behavioral interventions to assist patients in quitting, highlighting the importance of personalized quit plans.

The article discusses the latest pharmacotherapy options and the growing acceptance of e-cigarettes as potential tools for tobacco cessation, indicating a shift in strategies for helping patients quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: Identifying readiness to quit and designing a plan. Olenik, A., Mospan, CM.[2018]

Extended cognitive behavior therapy (CBT) significantly improved smoking abstinence rates at the 20-week follow-up, with 45% of participants achieving abstinence compared to 29% in the control group, indicating its effectiveness in promoting longer-term cessation.

While the difference in abstinence rates at 52 weeks was not significant (31% vs. 27%), the study suggests that CBT may help smokers maintain non-smoking status, especially for those with a history of depression who responded better to less intensive support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended cognitive behavior therapy for cigarette smoking cessation. Killen, JD., Fortmann, SP., Schatzberg, AF., et al.[2022]

The addition of contingency management (CM) to cognitive behavioral treatment (CBT) with episodic future thinking (EFT) significantly increased 24-hour tobacco abstinence rates from 20% to 50% among 54 treatment-seeking participants, indicating a more effective approach for smoking cessation.

While not statistically significant, the CM group showed improved in-treatment behaviors such as higher retention rates and more sessions attended, suggesting that CM may enhance overall treatment engagement and adherence to nicotine reduction guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects. Aonso-Diego, G., González-Roz, A., Krotter, A., et al.[2021]

The combination of cognitive-behavioral treatment (CBT) and episodic future thinking (EFT) for smoking cessation in a group of 29 smokers with substance use disorders was found to be acceptable, with a high satisfaction rating of 8.83 out of 10.

Despite the positive reception, adherence to the EFT component was low, with only 15.8% of participants practicing it as recommended, indicating a need for adjustments in future studies to enhance compliance and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. Aonso-Diego, G., González-Roz, A., Martínez-Loredo, V., et al.[2021]

Episodic future thinking (EFT) significantly reduces delay discounting and cigarette craving among smokers, suggesting it may help in smoking cessation efforts.

Imagining smoking-related illness (SRI) increased delay discounting but also reduced craving, indicating that while SRI can heighten the perceived value of immediate rewards, it may also help in managing cravings when combined with EFT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. Ruhi-Williams, P., King, MJ., Stein, JS., et al.[2022]

Cognitive-behavioral therapy for smoking cessation during pregnancy was effective, with 44% of the 74 participating women remaining abstinent until childbirth, and 93.1% of those abstinent maintained their status during the postpartum period.

Risk factors for treatment failure included having someone who smokes at home, a higher degree of nicotine dependence, and consuming more than three cups of coffee daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency and risk factors in the cognitive-behavioural treatment for smoking cessation in pregnancy]. Godá, T., Marcos, T., Corominas, J., et al.[2019]

Nurse-managed smoking cessation programs, which include a 15-minute personalized counseling session followed by a follow-up call, have shown to be one of the most effective interventions for helping pregnant women quit smoking, as measured by cotinine-validated abstinence.

Other approaches like nicotine replacement, hypnosis, and behavioral modifications were also evaluated, but more research is needed to determine their effectiveness in smoking cessation during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful interventions for smoking cessation in pregnancy. Barron, J., Petrilli, F., Strath, L., et al.[2019]

An office-based protocol that identifies and treats pregnant women who smoke can significantly increase quit rates, with a 30-70% increase in cessation for those smoking less than 20 cigarettes per day.

The intervention includes a brief five-step counseling session and pregnancy-specific educational materials, highlighting its effectiveness in promoting smoking cessation during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation during pregnancy. [2015]

Nicotine replacement therapy (NRT) is recommended as the safest and most effective option for helping pregnant women quit smoking, as other pharmacological treatments lack proven safety during pregnancy.

The review highlights the importance of assisting pregnant smokers in cessation efforts to reduce risks to both the mother and developing fetus, emphasizing the need for effective management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation in pregnancy. Rore, C., Brace, V., Danielian, P., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation: Identifying readiness to quit and designing a plan. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Extended cognitive behavior therapy for cigarette smoking cessation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Imagining the future can shape the present: A systematic review of the impact of episodic future thinking on substance use outcomes. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Efficiency and risk factors in the cognitive-behavioural treatment for smoking cessation in pregnancy]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Successful interventions for smoking cessation in pregnancy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation during pregnancy. [2015]

10. Hungary pubmed.ncbi.nlm.nih.gov

[Medical support of cessation for pregnant smokers]. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Pregnant women's responses to a tailored smoking cessation intervention: turning hopelessness into competence. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Smoking cessation in pregnancy. [2019]