Smoking CessationF2QNCT07181551
Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults
A study testing Forward to Quit (F2Q) in people with Smoking Cessation, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Forward to Quit (F2Q)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- Forward to Quit (F2Q)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forward to Quit (F2Q)Behavioural
A mobile health (mHealth) smoking cessation intervention designed specifically for transgender adults. Delivered via a secure website accessible by smartphone or tablet.
| Study group | Role | What they receive |
|---|---|---|
| F2Q Intervention | Experimental | Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults Receives: Behavioral: Forward to Quit (F2Q) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-baseline
Intervention feasibility
Feasibility will be met if retention rates are at least 80%.
Measured: 3 months post-baseline
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.
Measured: 3 month post-baseline
Remote biochemical data collection feasibility
Completion rate (percentage of eligible participants who submit biochemical samples for verification of tobacco abstinence)
Measured: 3 months post-baseline
Secondary outcomes (2)
Smoking cessation
Participants will be categorized as abstinent or not abstinent based on self-report.
Measured: 3 month post-baseline
Conceptual model covariates
Nicotine dependence and other conceptual model covariates will be assessed with validated survey items.
Measured: 3 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start14 Oct 2025
- Primary completion25 Mar 2026
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christina Sun, PhD, Principal investigator, Universtiy of Colorado Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181551
- Sponsor's protocol ID
- 22-2296
- Other IDs
- 5R34DA058191
- Acronym
- F2Q
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Unsure of where or how IPD would be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults
- ClinicalTrials.gov ID
- NCT07181551
- Acronym / sponsor ID
- F2Q / 22-2296
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- Dec 2031 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F2Q Intervention | Experimental | Behavioral: Forward to Quit (F2Q)Participants will receive access to the Forward to Quit (F2Q) mHealth smoking cessation intervention tailored for transgender adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forward 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. | Behavioural | F2Q Intervention |
Primary outcome
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.
Intervention feasibility
Time frame: 3 months post-baseline
Feasibility will be met if retention rates are at least 80%.
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.
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)
2 secondary outcomes
Smoking cessation
Time frame: 3 month post-baseline
Conceptual model covariates
Time frame: 3 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided. Unsure of where or how IPD would be shared
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Sun, PhD principal investigator
Universtiy of Colorado Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forward to Quit (F2Q) in people with Smoking Cessation, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability (time frame: 3 months post-baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.