Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07181551

Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults

This study evaluates the feasibility, acceptability, and preliminary efficacy of "Forward to Quit" (F2Q), a person-centered mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. The intervention was developed in collaboration with transgender individuals and gender-affirming healthcare providers. The study includes usability testing and a remote single-arm pilot trial. Primary outcomes include feasibility and acceptability of both the intervention and remote biochemical verification of smoking cessation. Secondary outcomes include self-reported and biochemically verified smoking cessation, as well as changes in psychosocial factors such as social support and gender affirmation. The goal is to inform a future large-scale trial and address tobacco-related health disparities in transgender populations.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identify with a gender different from sex assigned at birth
  • 18+ years of age
  • Report smoking at least 5 cigarettes per day
  • Have smoked 100+ cigarettes in their lifetime
  • Own a device that can access the Internet (e.g., tablet, smartphone)
  • Speak English
  • Be willing to submit biochemical samples to verify cessation
  • Be willing to use a website-based intervention to help with quit attempt
  • Be willing to set a quit date within 1 month of baseline assessment
  • Be willing to complete 3 months post-baseline and 6 months post-baseline assessments

Exclusion criteria

  • Do not meet inclusion criteria
  • Medical conditions precluding use of the carbon monoxide (CO) monitor or salivary cotinine testing
  • Current use of pharmacotherapies for nicotine dependence
  • Enrollment in another tobacco cessation program

Treatment and study plan

Forward to Quit (F2Q)

Behavioral

A mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. Delivered via a secure website accessible by smartphone or tablet.

Primary outcomes

  1. Intervention Acceptability

    Time frame: 3 months post-baseline

    We will assess participants' perceptions of information quality and usefulness as well as overall satisfaction with the intervention. If the average score across all items is >=6 on a 7-point scale for 90% of participants after using intervention for 3 months, we will consider intervention to be acceptable.

  2. Intervention feasibility

    Time frame: 3 months post-baseline

    Feasibility will be met if retention rates are at least 80%.

  3. Remote biochemical data collection acceptability

    Time frame: 3 month post-baseline

    We will measure participants' perceived difficulty, satisfaction, and comfort with remote biochemical verification. If scores are >=6 on a 7-point scale for 90% of participants, we will consider remote biochemical verification to be acceptable.

  4. Remote biochemical data collection feasibility

    Time frame: 3 months post-baseline

    Completion rate (percentage of eligible participants who submit biochemical samples for verification of tobacco abstinence)

Secondary outcomes

  1. Smoking cessation

    Time frame: 3 month post-baseline

    Participants will be categorized as abstinent or not abstinent based on self-report.

  2. Conceptual model covariates

    Time frame: 3 months post-baseline

    Nicotine dependence and other conceptual model covariates will be assessed with validated survey items.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: F2Q

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Sep 18, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.