Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals

NCT ID: NCT06654414

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-21

Brief Summary

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.

Detailed Description

Despite the substantial decrease in the prevalence of smoking over the past 50 years, there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. The prevalence of cigarette use in TGD individuals is 45.7 - 62.3%, compared to 39.8% in cisgender individuals. There are also disparities in e-cigarette use among TGD people relative to cisgender adults (26.5% vs. 5.5% in transgender and cisgender men, respectively). Transgender individuals may be particularly vulnerable to the consequences of tobacco use, as hormone therapy among those who smoke increases heart disease risk, and smoking may hinder recovery from gender-affirming surgeries. Stigma, discrimination, gender dysphoria, and other gender minority stressors contribute to tobacco use disparities. Enacted stigma and discrimination toward TGD individuals are common (reported by over 75% of participants in some samples), and experiencing stigma or discrimination increases the odds of current cigarette smoking, e-cigarette use/vaping, and dual use among TGD people. Gender dysphoria and gender minority stress may also lead to and/or exacerbate disparities in anxiety and depression, which are major impediments to smoking cessation that are more prevalent among TGD than cisgender individuals. Anxiety symptoms co- occur with smoking at high rates and significantly impair cessation success. Similarly, depressed mood and major depressive disorder, both more common among individuals who smoke than among those who do not, are associated with reduced odds of cessation. Therefore, gender minority stress and high prevalence rates of anxiety and depression render TGD individuals particularly vulnerable to smoking cessation difficulties. A tailored smoking cessation intervention that builds cognitive behavioral skills for cessation as well as reduces gender minority stress and associated anxiety and depression symptoms has strong potential to mitigate tobacco use disparities among TGD individuals. The investigators propose to adapt an existing smoking cessation intervention (known as QUIT) to address the unique needs of TGD people. In focus groups with TGD individuals who use tobacco (N = up to 32) and providers (N = 8), the investigators will explore the ways in which gender minority stressors and associated anxiety/depression compromise cessation as well as identify content in the current version of the QUIT intervention that does and does not meet their needs. Providers will also comment on anticipated implementation barriers. Following the ADAPT-ITT model, the qualitative data will inform the adaptation of the intervention. The investigators will then test the feasibility and acceptability of the adapted intervention (QUIT+) in a pilot RCT (N = 60); the investigators will also assess for signals of clinically meaningful change in biologically verified 7-day point prevalence abstinence, average number of cigarettes smoked, gender minority stress, anxiety and depression symptoms, and distress tolerance. If deemed to be feasible and acceptable, the intervention will be ready for a hybrid efficacy/effectiveness trial.

Conditions

Smoking Cessation; Depression; Anxiety; Nicotine Dependence; Gender Minority Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRIDE QUIT

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 Type: EXPERIMENTAL

PRIDE QUIT

Intervention Type: BEHAVIORAL

This is an adapted behavioral intervention based on the integrated treatment for smoking cessation, anxiety, and depressed mood, known as QUIT, for persons with HIV. Through our treatment adaption process of QUIT (guided by Aim 1 and 2 data), PRIDE QUIT will be a Cognitive-Behavioral therapy-based intervention tailored for transgender and gender diverse (TGD) individuals, aimed at to helping participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance.

There will be three major assessments: baseline (T1), at the end of the intervention (T2), and a three-month follow-up visit (T3). This intervention group will likely receive 6-10 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.

Enhanced Treatment As Usual (ETAU)

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment As Usual (ETAU)

Intervention Type: BEHAVIORAL

Brief counseling, the option of nicotine replacement therapy, and referral to the Quit Line.

Interventions

PRIDE QUIT

This is an adapted behavioral intervention based on the integrated treatment for smoking cessation, anxiety, and depressed mood, known as QUIT, for persons with HIV. Through our treatment adaption process of QUIT (guided by Aim 1 and 2 data), PRIDE QUIT will be a Cognitive-Behavioral therapy-based intervention tailored for transgender and gender diverse (TGD) individuals, aimed at to helping participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance.

There will be three major assessments: baseline (T1), at the end of the intervention (T2), and a three-month follow-up visit (T3). This intervention group will likely receive 6-10 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.

Intervention Type: BEHAVIORAL

Enhanced Treatment As Usual (ETAU)

Brief counseling, the option of nicotine replacement therapy, and referral to the Quit Line.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• aged 18+
• self-reported difference between sex assigned at birth and gender identity
• current use of combustible cigarettes OR recent use of combustible cigarettes (defined as at least 5 cigarettes-per-day at some point within the past 6 months) OR current use of nicotine-containing e-cigarettes with use of combustible cigarettes in the past 6 months (defined as 5 cigarettes-per-day)
• English-speaking.

Exclusion Criteria

• unable to provide informed consent
• current interfering untreated or unstable major health condition that is event during screening (e.g., active mania, current psychosis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Conall O'Cleirigh

Director of Behavioral Medicine Program/Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Conall M O'Cleirigh, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital, Behavioral Medicine Program

Amelia Stanton, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Massachusetts General Hopsital

Boston, Massachusetts, United States

Boston University - Charles River Campus

Boston, Massachusetts, United States

Fenway Health

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R21CA292185-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB2024-3

Identifier Type: -

Identifier Source: org_study_id