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Behavioral Intervention

Adapted Intervention for Smoking Cessation

N/A

Waitlist Available

Led By Conall M O'Cleirigh, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English-speaking.

Self-reported difference between sex assigned at birth and gender identity

Must not have

Unable to provide informed consent

Current interfering untreated or unstable major health condition that is evident during screening (e.g., active mania, current psychosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (t3; approx. 6 months post-baseline)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how stress related to gender identity affects smoking habits in transgender and gender diverse individuals. The study will modify an existing smoking cessation program to better suit the needs of this population and test

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this trial focuses on behavioral interventions rather than medication, side effects may include discomfort from withdrawal symptoms such as irritability, cravings, or difficulty concentrating during the smoking cessation process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English.

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My gender identity differs from the sex I was assigned at birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form.

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I do not have any untreated major health issues like active mania or psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (t3; approx. 6 months post-baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (t3; approx. 6 months post-baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (t3; approx. 6 months post-baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility

Secondary study objectives

7-Day Point Prevalence Abstinence

Anxiety and Depressive Symptoms

Average Number of Cigarettes Smoked Per Day In The Past Week

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PRIDE QUITExperimental Treatment1 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 Control1 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.

0 / 4Eligibility criteria met