RightFit
RecruitingNot applicable

Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study will adapt a skills-based program to help transgender and gender diverse adults quit smoking. It will look at how stress, anxiety, and depression affect quitting. A small trial will test whether the adapted program is practical to use and acceptable to participants.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • Your gender identity differs from the sex you were assigned at birth.
  • You smoked at least 5 regular cigarettes a day during any week in the past month. You must also either have a breath carbon monoxide level of at least 8 ppm, or use nicotine e-cigarettes and have a saliva cotinine level of at least 30 ng/mL. Cotinine is a sign of nicotine use.
  • You want to stop using tobacco and score at least 5 on a survey about your desire to quit.
  • You speak English.

Who can't join

  • You cannot give informed consent, meaning you cannot understand the study and agree to take part.
  • You have a major untreated or unstable health condition that could interfere with the study, such as bipolar disorder or current psychosis (trouble knowing what is real).
  • You are currently getting counseling to quit smoking.
  • You took part in the study's Aim 1a activities.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. aged 18+ 2. self-reported difference between sex assigned at birth and gender identity 3. current use of combustible cigarettes (defined as self-reported 5 combustible cigarettes per day in any week in the past month and a carbon monoxide \[CO\] expired-air reading of ≥8ppm) OR current use of nicotine-containing e-cigarettes (defined by saliva cotinine level of ≥30ng/mL) with use of combustible cigarettes (5 cigarettes per day in any week in the past month) 4. desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire) 5. English-speaking. Exclusion Criteria: 1. unable to provide informed consent 2. current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis) 3. current use of psychotherapy for smoking cessation 4. participation in Aim 1a procedures.

Study sites (3)

MA