Mindfulness for Smoking Cessation

Overseen By Tami P Sullivan, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Under 18, Moving soon, others

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

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help Northern Plains Tribal women quit smoking. It incorporates mindfulness, a type of meditation that aids in focus and stress reduction. The goal is to determine if this method, which takes cultural and trauma experiences into account, is practical and satisfying for those who have faced intimate partner violence. Women who smoke at least five cigarettes a day and have experienced such violence might be suitable for this trial. If successful, this approach could be adapted for other Tribal communities. As an unphased trial, participants contribute to innovative research that may lead to culturally sensitive smoking cessation methods.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mindfulness smoking cessation intervention is safe?

Research has shown that mindfulness programs to help people stop smoking are generally safe. Studies have found no major safety issues or harmful effects from these programs. Mindfulness helps people notice their cravings and reactions, aiding in reducing smoking without causing harm.

In past trials, participants handled mindfulness programs well and did not report any major negative effects. This suggests that mindfulness is a gentle way to help people quit smoking.

While success in quitting smoking can vary, the safety information is encouraging. This makes mindfulness a potentially safe choice for those interested in these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Smoking Cessation Intervention because it offers a culturally tailored, trauma-informed approach specifically designed for Northern Plains Tribal women who have experienced Intimate Partner Violence (IPV). Unlike standard smoking cessation treatments like nicotine replacement therapy or prescription medications, this intervention focuses on mindfulness techniques to help individuals manage stress and cravings, which can be particularly beneficial for those with trauma histories. By addressing both the psychological and cultural needs of the participants, this approach has the potential to be more effective and supportive than traditional methods.

What evidence suggests that this mindfulness intervention is effective for smoking cessation?

Research has shown that mindfulness-based programs can help people quit smoking. Studies have found that these programs lead to higher quit rates compared to other methods. For instance, one study found that people using mindfulness were more likely to stop smoking after six months. Mindfulness also helps people handle stress and cravings, aiding long-term success. In this trial, participants will experience a culturally tailored, trauma-informed mindfulness smoking cessation intervention. This suggests mindfulness could be a useful tool for quitting smoking, especially when adapted to fit different cultural needs. ^{1 6 7 8 9}

Who Is on the Research Team?

Patricia Nez Henderson, MD, MPH

Principal Investigator

Black Hills Center for American Indian Health

Are You a Good Fit for This Trial?

This trial is for Northern Plains Tribal women over 18 years old who smoke at least 5 cigarettes daily and have experienced physical or psychological intimate partner violence. It aims to help them quit smoking using a program designed with their cultural background and personal experiences in mind.

Inclusion Criteria

Report smoking ≥ 5 cigarettes per day

A victim of physical and/or psychological IPV

I am 18 years old or older.

Exclusion Criteria

Plans on moving out of the region in the next six months

I am unable to understand and give consent for treatment.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo an 8-session culturally tailored, trauma-informed mindfulness smoking cessation intervention

8 weeks

Follow-up

Participants are monitored for quit attempts and biochemically-verified smoking abstinence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Smoking Cessation Intervention

Trial Overview The study tests a new way to help people stop smoking, focusing on mindfulness techniques that are sensitive to the culture and trauma history of participants. The goal is to see if this approach is practical, well-received, and satisfying for the women involved.

How Is the Trial Designed?

Group I: 48 Northern Plains Tribal women smokers who have experienced Intimate Partner Violence (IPV). Experimental Treatment 1 Intervention

These participants will experience a culturally tailored, trauma-informed mindfulness smoking cessation intervention.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07013968

Healing Within: Mindfulness Smoking Cessation ... Using a highly participatory approach, this study will assess the feasibility, acceptability, and satisfaction with a culturally tailored, trauma-informed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9379793/

Mindfulness-Based Smoking Cessation Delivered Through ... The primary outcomes are biochemically verified smoking abstinence at 8, 12, and 24 weeks after the start of treatment. Secondary outcomes include the frequency ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06357767

Smoking Cessation Intervention for American Indian ... The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/13591053251371955

Mindfulness-based interventions for smoking cessation in ... The primary outcome was smoking cessation at 6 months or longer. MBIs showed significantly higher odds of smoking cessation than comparators (OR ...

5. ajpmonline.org ajpmonline.org/article/S0749-3797(23)00343-4/fulltext

Promoting the Use of Evidence-Based Practice for Those ... Another negative outcome of this lack of focus on effectiveness is that IPV intervention programs are almost always exclusively involuntary and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030646031730031X

Efficacy of mindfulness meditation for smoking cessation Abstinence from smoking was the primary outcome; secondary outcomes included reduction in use, and cravings.

7. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013696.pub2/full

Mindfulness for smoking cessation - Jackson, S - 2022 We did not detect a clear benefit of mindfulness‐based smoking cessation interventions for increasing smoking quit rates or changing mental ...

8. rand.org rand.org/pubs/research_reports/RR1343.html

Mindfulness Meditation for the Treatment of Tobacco Use The primary outcome of interest was smoking/tobacco cessation. Other outcomes of interest included reduction in use, decrease in cravings, ...

9. recoveryanswers.org recoveryanswers.org/research-post/can-mindfulness-help-people-quit-smoking-while-also-reducing-high-risk-drinking/

Can a mindfulness intervention help people quit smoking ... Previous clinical trials have produced promising results suggesting this intervention can prevent substance use disorder relapse as well as standard relapse ...