Adapted Intervention for Smoking Cessation

No longer recruiting at 2 trial locations

Overseen By Conall M O'Cleirigh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Active mania, current psychosis, others

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

Compensation: Varies

Number of Visits: 6

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help transgender and gender diverse (TGD) individuals quit smoking by addressing unique stressors such as stigma and gender dysphoria. It will test an adapted smoking cessation program called PRIDE QUIT, which uses tailored Cognitive-Behavioral Therapy (a type of talk therapy) to support quitting and improve mental health. Participants will also receive nicotine patches to help reduce cravings. This trial is suitable for English-speaking individuals who identify as transgender or gender diverse and have smoked or used nicotine in the past six months. As an unphased trial, it offers a unique opportunity to contribute to research specifically tailored for the TGD community.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this adapted intervention is safe for smoking cessation among TGD individuals?

Research shows that the PRIDE QUIT program employs cognitive-behavioral techniques. These techniques are well-researched and commonly used in other programs to help people quit smoking. Although specific safety data for PRIDE QUIT is unavailable, cognitive-behavioral therapy is generally safe and well-tolerated.

Participants in the PRIDE QUIT group also use nicotine patches applied to the skin. Studies have found these patches to be safe for most people. Some users might experience mild side effects such as skin irritation, dizziness, or trouble sleeping, but these are usually manageable.

Since PRIDE QUIT is in the "Not Applicable" phase, its safety data may not be as detailed as in later-stage studies. However, the program's components, like therapy and nicotine patches, are widely used and have established safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRIDE QUIT intervention because it tailors smoking cessation strategies specifically for transgender and gender diverse (TGD) individuals. Unlike traditional methods that might only offer nicotine patches or general counseling, PRIDE QUIT incorporates Cognitive-Behavioral Therapy (CBT) to address unique stressors faced by TGD individuals, such as minority stress, anxiety, and depression. This personalized approach not only aims to help participants quit smoking but also to enhance mental health and distress tolerance, offering a comprehensive support system that standard treatments lack.

What evidence suggests that the PRIDE QUIT intervention could be effective for smoking cessation among transgender and gender diverse individuals?

Research has shown that the PRIDE QUIT program, a treatment arm in this trial, is designed for transgender and gender diverse individuals and may aid in smoking cessation. Early results suggest that this program, which employs therapy to alter thinking and behavior while addressing stress related to gender identity, can increase smoking cessation rates. In one study, 38.8% of participants quit smoking after one month, and 24.4% remained smoke-free after a year. These findings indicate that PRIDE QUIT's dual focus on smoking and stress may effectively help TGD individuals quit smoking. ^{4 6 7 8 9}

Who Is on the Research Team?

Conall O'Cleirigh, PhD

Principal Investigator

Massachusetts General Hospital, Behavioral Medicine Program

Amelia Stanton, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for transgender and gender diverse individuals who are dealing with nicotine addiction, possibly alongside depression, anxiety, or gender dysphoria. Participants should be interested in quitting smoking and willing to try new cessation methods.

Inclusion Criteria

My gender identity differs from the sex I was assigned at birth.

I currently smoke cigarettes, have recently smoked, or use nicotine e-cigarettes.

Exclusion Criteria

I am unable to understand or sign the consent form.

I do not have any untreated major health issues like active mania or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the adapted smoking cessation intervention (QUIT+) tailored for transgender and gender diverse individuals, including cognitive-behavioral therapy-based strategies and transdermal nicotine patches.

10 weeks

6-10 weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of smoking abstinence, gender minority stress, anxiety, and depression symptoms.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PRIDE QUIT

Trial Overview The study tests two approaches: 'Enhanced Treatment As Usual' (ETAU), which is the standard support for quitting smoking, against 'PRIDE QUIT', a tailored intervention considering the unique stressors faced by transgender and gender expansive individuals.

How Is the Trial Designed?

Group I: PRIDE QUIT Experimental Treatment 1 Intervention

Participants in this adapted intervention arm (n=30) will receive empirically-based, Cognitive-Behavioral therapy-based strategies, tailored for transgender and gender diverse (TGD) individuals, which aims to help participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. This intervention group will likely receive 6-10 active weekly sessions, with the quit day set around session 4-6. They will also receive transdermal nicotine patches (TNP) for a period of 8 weeks prior to the quit session.

Group II: Enhanced Treatment As Usual (ETAU) Active Control 1 Intervention

Participants in this arm (n=30) will receive enhanced treatment as usual at Fenway Health. These participants will attend one session (brief counseling), will come to the clinic for weekly assessments only, and receive the option of transdermal nicotine patch (TNP) and referral to the Quit Line.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

A meta-analysis of 18 studies involving 3756 papers found no significant difference in the rates of adverse events (AEs) like cough, oral irritation, and nausea between nicotine electronic cigarettes (ECs) and nicotine replacement therapies (NRTs).

The similar incidence of AEs suggests that the preference for nicotine ECs over NRTs is not driven by differences in adverse effects, indicating a need for further research to explore other factors influencing user choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. Anandan, AS., Leung, J., Chan, GCK., et al.[2023]

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06654414

Project QUIT+: Adapting and Testing a Smoking Cessation ... A tailored smoking cessation intervention that builds cognitive behavioral skills for cessation as well as reduces gender minority stress and associated anxiety ...

2. academic.oup.com academic.oup.com/ntr/advance-article/doi/10.1093/ntr/ntaf080/8109343

“It Took Me on a Journey Other Than Just to Stop Smoking ... Study retention was 80.0% (16/20). Most exit survey respondents attended ≥4 volunteer activity sessions (62.5%; 10/16) and ≥4 cessation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6821204/

Evaluation of a Randomized Clinical Trial Comparing ... Overall quit rates were slightly higher for treatment completers at 1 (38.8%), 3 (25.5%), 6 (29.7%), and 12 months (24.4%). Multiple imputation mixed-effects ...

4. medresearch.umich.edu medresearch.umich.edu/labs-departments/clinical-studies/incentives2quit

Incentives2Quit | University of Michigan Medical School The survey found that most peers strongly agree that smoking is harmful to health with 4 out of 10 respondents having had negative consequences of tobacco use.

5. nature.com nature.com/articles/s41598-024-78207-7

Anti-industry beliefs and attitudes mediate the effect of ... These findings suggest that LGBTQ + -tailored cues in anti-smoking messaging may promote quit intentions indirectly through influencing young adult SMW's ...

6. tobaccopreventioncessation.com tobaccopreventioncessation.com/Do-US-quitsites-present-information-related-to-providing-services-for-LGBTQ-individuals,191457,0,2.html

Do US quitsites present information related to providing ... The present study audited quitsites to determine the presence of information regarding services for LGBTQ individuals.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10305739/

Tobacco Cessation and Prevention Interventions for Sexual ... This scoping review takes stock of the social and behavior change theories that have underpinned tobacco interventions tailored to sexual and/or gender minority ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08986

A Smoking Cessation Intervention (PRIDE QUIT) for the ... This clinical trial studies whether a smoking cessation intervention, Promoting Recovery in Diverse Experiences-Quitting Tobacco (PRIDE QUIT), improves quit ...

9. michigan.gov michigan.gov/documents/mdhhs/Michigan_LGBTQ_Using_and_Quitting_Tobacco_Report_749027_7.pdf

Using and Quitting Tobacco: Results from Surveys and ... As shown in Figure 9, three-quarters of respondents agreed or strongly agreed that vaping and e-cigarettes are a health threat to LGBTQ+ communities.