Recruiting
Phase 2
Phase 3

SGM Smoking Cessation

Sponsor:

University of Oklahoma

Code:

NCT06820034

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Empowering Cessation for the ACS South

Study Details

Brief 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. 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.

Conditions

Smoking Cessation

Study ID

NCT06820034

Start date

Aug 14, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Exclusion criteria:

  • 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)

Inclusion criteria will be:

1. ≥ 18 years old
2. sexual and/or gender minority-identified (SGM) (see definition below)
3. living in Oklahoma, Texas, or Arkansas (verified by address)
4. a current cigarette smoker (see definition)
5. willing to quit smoking within 30 days of enrollment (see definition)
6. ability to read and speak English 'well' or 'very well'
7. ≥ weekly internet access
8. willing and able to participate in SGM-serving volunteer activities.
9. 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).

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smoking cessation support + volunteering

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). 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.

no intervention: Smoking cessation support ONLY

Participants 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).

Interventions

Empowering Cessation for the ACS South

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.

Primary outcome measure

  • Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks [ Time Frame: 26 weeks post-quit-date ]

Central Contacts and Locations

Central contacts

Locations

University of Oklahoma Health Campus

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Julia McQuoid, PhD

More Information

Sponsor

University of Oklahoma

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • smoking cessation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-05-11.