Clinical trial NCT06654414: Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals
Official title: Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Depression
Anxiety
Nicotine Dependence
Gender Minority Stress
Keywords: Smoking Cessation
Smoking
Tobacco Use
Tobacco Use Disorder
Substance-Related Disorder
Nicotine
Anxiety
Depression
Transgender Individuals
Gender Expansive Individuals
Gender Minority Stress
Distress Tolerance
Quitting
Cognitive Behavioral Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Acceptability
timeFrame: Through the end of treatment intervention, approximately 10 weeks
measure: Feasibility
timeFrame: Through participants' enrollment, approximately 6 months
Secondary outcomes:
measure: 7-Day Point Prevalence Abstinence
timeFrame: At the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Gender Minority Stress
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Average Number of Cigarettes Smoked Per Day In The Past Week
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Nonbinary Distal Stress (Nbi-DMSS )
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Proximal Minority Stress (Nbi-PMSS)
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Nonbinary Resilience (Nbi-RS)
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Severity of Nicotine Dependence
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
measure: Anxiety and Depressive Symptoms
timeFrame: At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hopsital
state: Massachusetts
city: Boston
country: United States
facility: Boston University - Charles River Campus
state: Massachusetts
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Behavioral Medicine Program
name: Conall M O'Cleirigh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Amelia Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
References: