CClinicalTrials.gg
Active, not recruitingNCT07181551F2QUpdated Jun 30, 2026

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

An interventional study of Forward to Quit (F2Q) in Smoking Cessation, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Smoking Cessation

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03

In context

Smoking Cessation

304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.

This study's enrollment of 47 is below the median of 154 across 285 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    F2Q Intervention

    Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults

    Behavioral: Forward to Quit (F2Q)

Interventions

  • BehavioralForward to Quit (F2Q)

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

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What researchers measure

Primary outcomes

  1. Intervention Acceptability

    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.

    Time frame: 3 months post-baseline

  2. Intervention feasibility

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

    Time frame: 3 months post-baseline

  3. Remote biochemical data collection acceptability

    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.

    Time frame: 3 month post-baseline

  4. Remote biochemical data collection feasibility

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

    Time frame: 3 months post-baseline

Secondary outcomes

  1. Smoking cessation

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

    Time frame: 3 month post-baseline

  2. Conceptual model covariates

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

    Time frame: 3 months post-baseline

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Study locations

1 site
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
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References and documents

Individual participant data

Plan to share: Undecided — Unsure of where or how IPD would be shared

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07181551
Lead sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Sep 18, 2025
Start date
Oct 14, 2025
Primary completion
Mar 25, 2026
Completion
Dec 2031 (estimated)
Last update
Jun 30, 2026

Study contacts

Christina Sun, PhD
principal investigator · Universtiy of Colorado Anschutz Medical Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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