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

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.

Conditions

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Enhanced Treatment As Usual (ETAU)

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Conall M O'Cleirigh, PhD · Massachusetts General Hospital, Behavioral Medicine Program

• Amelia Stanton, PhD · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2025-03-18

Completion

2025-03-21

Countries

• United States

Study Locations