Adapted Intervention for Smoking Cessation

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Stigma, discrimination, gender dysphoria, and other gender minority stressors likely contribute to these disparities, and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression, both of which are more common among TGD individuals and among those who smoke relative to comparison samples. This study will (1) explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals, identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs; (2) adapt an existing smoking cessation intervention for TGD individuals; and (3) evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial.

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 data supports the effectiveness of the treatment PRIDE QUIT for smoking cessation?

Research shows that repeated support in quitting smoking and adherence to treatment plans can improve long-term success in quitting. Additionally, enhancing nicotine replacement therapy (NRT) has been shown to positively impact quit outcomes, suggesting that similar supportive interventions like PRIDE QUIT could be effective. ^{1 2 3 4 5}

Is the Adapted Intervention for Smoking Cessation safe for humans?

The research articles reviewed do not provide specific safety data for the Adapted Intervention for Smoking Cessation or PRIDE QUIT. However, they discuss adverse events related to smoking cessation medications and electronic cigarettes, which are generally considered safe but can have side effects like nausea or headaches. ^{6 7 8 9 10}

How is the PRIDE QUIT treatment for smoking cessation different from other treatments?

PRIDE QUIT is unique because it adapts an expert system intervention that provides personalized feedback to guide individuals through the stages of quitting smoking, potentially enhanced by proactive telephone counseling or a computer system for nicotine fading, which may increase its effectiveness compared to standard self-help methods. ^{11 12 13 14 15}

Research Team

Conall O'Cleirigh, PhD

Principal Investigator

Massachusetts General Hospital, Behavioral Medicine Program

Amelia Stanton, PhD

Principal Investigator

Boston University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Long-Term Outcomes From Repeated Smoking Cessation Assistance in Routine Primary Care. [2020]

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

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Medication Adherence in Tobacco Cessation Clinical Trials. [2023]

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

Self-help interventions for older smokers. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of intervention components for producing long-term abstinence from smoking: a factorial screening experiment. [2018]

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

Feasibility and effectiveness of a community-based smoking cessation intervention in a racially diverse, urban smoker cohort. [2021]

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

Project Impact: a pharmacotherapy pilot trial investigating the abstinence and treatment adherence of Latino light smokers. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Common adverse events of electronic cigarettes compared with traditional nicotine replacement therapies: A systematic review and meta-analysis. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Development, implementation and evaluation of a program for the cessation of smoking for adolescents and young adult smokers]. [2019]

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

Counselor and stimulus control enhancements of a stage-matched expert system intervention for smokers in a managed care setting. [2022]

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

Self-help interventions for smoking cessation. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility, Efficacy, and Cost Analysis of Promoting Smoking Cessation at Outdoor Smoking "Hotspots": A Pre-Post Study. [2019]

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

Using Roy's adaptation model when caring for a group of young women contemplating quitting smoking. [2019]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Computer-assisted smoking cessation]. [2008]