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Smoking CessationPhase 2/3CHERCNCT06820034

Empowering Cessation ACS South Region

A Phase 2/3 study testing Empowering Cessation for the ACS South in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Sexual and/or gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Empowering Cessation for the ACS South
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
14 Aug 2025to 31 Dec 2028
Phase
Phase 2/3
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years old
  • sexual and/or gender minority-identified (SGM) (see definition below)
  • living in Oklahoma, Texas, or Arkansas (verified by address)
  • a current cigarette smoker (see definition)
  • willing to quit smoking within 30 days of enrollment (see definition)
  • ability to read and speak English 'well' or 'very well'
Show all 13Show fewer
  • ≥ weekly internet access
  • willing and able to participate in SGM-serving volunteer activities.
  • own a smartphone
  • Sexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state)." Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by "Trans male/Trans man;" "Trans female/Trans woman;" "Gender queer/Gender non-conforming;" "Different identity (please state)" or a binary identity (male or female) non-concordant with natal sex.
  • Current cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes "every day" or "some days".
  • High SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'. High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index.
  • Willingness to quit smoking will be assessed with a single item: "Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes/no)". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the "Preparation" stage of change).

Who cannot join

  • Currently using other smoking cessation treatments.
  • Unable or unwilling to use Nicotine Replacement Therapy (NRT)
  • Serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler Psychological Distress (PD) Scale-6 19)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julia McQuoid, PhD contact

405-271-6872

julia-mcquoid@ouhsc.edu

David Bradley, BA contact

405-934-6811

david-bradley@ou.edu

United States1 site, 1 recruiting

  • University of Oklahoma Health Campus

    Oklahoma City, Oklahoma, 73104

    Julia McQuoid, PhD, 510-672-0394, julia-mcquoid@ou.edu

    David Bradley, BA, 405-934-6811, david-bradley@ou.edu

    Recruiting

Other trials in United States

About this study

Official title: Empowering Smoking Cessation for People With High Levels of Stress and Low Social Support in Oklahoma and the ACS South Region

Sexual and/or gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. This community-engaged and remotely-delivered Research Scholar Grant project will evaluate an empowerment-based smoking cessation intervention tailored for SGM people in high-stigma places. In partnership with Freedom Oklahoma (OK) and a Community Advisory Board from Arkansas (AR) and Texas (TX) this projects aims to: (1) Adapt SGM-serving volunteer activities from the Oklahoma intervention pilot study for delivery in nearby states; (2) Test intervention efficacy among SGM adults in OK, AR, and TX; (3) Identify treatment mechanisms.

Read the detailed description

We will enroll 398 participants for the proposed RCT of the intervention. Randomization will occur prior to the onboarding meeting using screening survey responses. We will stratify by gender (cisgender man, cisgender woman, gender minority), sexual orientation (gay/lesbian, bisexual/pansexual/queer, all other sexual orientations), age (18-34 vs. ≥ 35 years old), and state of residence.

In a 2-arm, 12-week randomized controlled trial (RCT) with follow-up at 26 weeks, N=398 SGM adults willing to quit smoking cigarettes will be randomized to a control arm (n=199) (i.e., remote cessation support via the National Cancer Institute's (NCI) smoking cessation app64 and mailed NRT64) or a treatment arm (n=199) that adds online SGM-serving volunteer activity participation (≥4 sessions) and a digital hub to foster social support across sites.

All proposed activities will be conducted remotely (i.e., via phone/text, email, web-based platforms, a private Facebook group, and Zoom video chat) to maximize accessibility and scalability.

Being tested
Empowering Cessation for the ACS South
Keywords
smoking cessation
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empowering Cessation for the ACS SouthOther

    All participants (N=400) will receive remotely-delivered smoking cessation support comprised of the National Cancer Institute's (NCI) free smoking cessation app and 12 weeks of mailed over-the-counter NRT (nicotine patches, gum or lozenges).. While receiving smoking cessation support, participants in the intervention group (n=200) will also engage in SGM-serving online volunteer activities (≥4 weekly sessions lasting ~1.5 hours each), the protocols for which will be developed in Phase 1 to address the needs of OK, AR, and TX communities. Volunteer sessions will be facilitated by an SGM culturally-competent facilitator employed by the research team (i.e., community partner organizations will not run volunteer sessions). The intervention group will also be added to a digital hub (i.e., a private Reddit group) for 12 weeks to foster social support and exchange of ideas between participants/community partners across the three states.

Study groups in NCT06820034
Study groupRoleWhat they receive
Smoking cessation support + volunteeringExperimentalThis group will receive remotely-delivered smoking cessation support by using the National Cancer Institute's smoking cessation app and receive combination nicotine replacement therapy (NRT; i.e., lozenges/gum, patches). Additionally, they will engage in sexual and/or gender minority (SGM)-serving online volunteer activities (≥4 sessions) and a digital hub to foster interaction across Oklahoma, Texas, and Arkansas.
Receives: Other: Empowering Cessation for the ACS South
Smoking cessation support ONLYNo interventionParticipants in this group will receive remotely-delivered smoking cessation support by using the National Cancer Institute's smoking cessation app and receive combination nicotine replacement therapy (NRT; i.e., lozenges/gum, patches).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks

    Self-reported smoking cessation abstinence will be biochemically verified with the iCOQuit Smokerlyzer expired carbon monoxide device 26 weeks after the participant's quit smoking date.

    Measured: 26 weeks post-quit-date

Secondary outcomes (12)

  1. Social Support

    Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale.

    5-point Likert scale; Strongly disagree = least support ... Strongly agree = most support

    Measured: Week 0; Week 12

  2. Smoking intensity

    -Smoking intensity will be assessed by past-week smoking days and past-week cigarettes per smoking day.

    Greater number of smoking days and great number of cigarettes per day = greater smoking intensity

    Measured: Week 0, Week 12, Week 26

  3. Adaptive coping with minority stress

    Brief- Coping Orientation to Problems Experienced Inventory (COPE) [adapted]

    5-point Likert scale; Strongly disagree to Strongly agree. Higher score = more coping

    Measured: Week 0; Week 12

  4. Self-efficacy

    -Self-Efficacy Scale/Confidence (SESC) Scale of 10 Very confident to 1 not at all confident. Higher score = greater self-efficacy to quit smoking

    Measured: Week 0, Week 12, Week 26

  5. Motivation to quit smoking

    -Motivation to change (Stages of Change [SoC] scale) 0 (Not at all ready)-----------------------10 (Extremely ready/already quit) Higher score = more motivation to quit smoking

    Measured: Week 0, Week 12, Week 26

  6. Internalized transphobia

    Gender Minority Stress and Resilience: Internalized transphobia subscale 5-point Likert scale; Strongly disagree to Strongly agree Higher score = greater internalized transphobia

    Measured: Week 0; Week 12

  7. Prosociality

    Well-Being in Prosociality [Chi K, Almeida DM, Charles ST, et al. Daily prosocial activities and well-being: Age moderation in two national studies. Psychology and Aging 2021;36(1):83.] 5-point Likert Scale: Strongly agree to Strongly disagree Higher score indicates greater prosociality

    Measured: Week 0; Week 12

  8. Nicotine Replacement Therapy (NRT) Adherence

    Medication Adherence Questionnaire (MAQ) Yes=0; No=1; higher score = greater adherence

    Measured: Weeks 1, 3, 5, 7, 9, 11

  9. Smoking cessation app engagement

    Self-report of number of times per day participant opened app, on average, over the past week. Greater number of times opened = greater engagement

    Measured: Weeks 3, 5, 7, 9, 11

  10. Intervention satisfaction

    Validated measures of intervention feasibility, acceptability, and appropriateness (Weiner et al, 2017) 5 point ordinal scale from "completely disagree=0" to "completely agree=4"; higher score = greater intervention satisfaction

    Measured: Weeks 3, 5, 7, 9, 12

  11. Sexual Orientation Identity Pride

    Lesbian, Gay, and Bisexual Identity Scales: Identity Concealment Motivation subscale; Internalized Homonegativity; Identity Acceptance Concerns 6-point scale: 1=Disagree strongly... 6=Strongly agree Higher score = greater identity concerns

    Measured: Week 0, Week 12

  12. Gender identity and expression pride

    Gender Minority Stress and Resilience: Gender Identity \& Expression Pride subscale 5-point Likert scale; Strongly disagree to Strongly agree Higher score = greater gender identity and expression pride

    Measured: Week 0, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start14 Aug 2025
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820034
Sponsor's protocol ID
17874
Other IDs
1181502
Acronym
CHERC
Status last verified
May 2026
First submitted
28 Jan 2025
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Empowering Cessation for the ACS South in people with Smoking Cessation, run by University of Oklahoma 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 13 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 May 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Julia McQuoid, PhD (405-271-6872, julia-mcquoid@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks (time frame: 26 weeks post-quit-date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06820034.

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 11 May 2026.

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