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Recruiting Phase 2, Phase 3 NCT06820034

NCT06820034 Empowering Cessation ACS South Region

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Clinical Trial Summary
NCT ID NCT06820034
Status Recruiting
Phase Phase 2, Phase 3
Sponsor University of Oklahoma
Condition Smoking Cessation
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2025-08-14
Primary Completion 2028-06-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 100 Years
Study Type INTERVENTIONAL
Interventions
Empowering Cessation for the ACS South

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 400 participants in total. It began in 2025-08-14 with a primary completion date of 2028-06-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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).

Contact & Investigator

Central Contact

Julia McQuoid, PhD

✉ julia-mcquoid@ouhsc.edu

📞 405-271-6872

Principal Investigator

Julia McQuoid, PhD

PRINCIPAL INVESTIGATOR

University of Oklahoma

Frequently Asked Questions

Who can join the NCT06820034 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06820034 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT06820034 currently recruiting?

Yes, NCT06820034 is actively recruiting participants. Contact the research team at julia-mcquoid@ouhsc.edu for enrollment information.

Where is the NCT06820034 trial being conducted?

This trial is being conducted at Oklahoma City, United States.

Who is sponsoring the NCT06820034 clinical trial?

NCT06820034 is sponsored by University of Oklahoma. The principal investigator is Julia McQuoid, PhD at University of Oklahoma. The trial plans to enroll 400 participants.

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