Status:
NOT_YET_RECRUITING
Developing Empowering Smoking Cessation
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
Brief Summary
Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relap...
Detailed Description
Specific Aims Aim 1 (Inform): Prioritize factors associated with smoking cessation for people with high levels of social stress to inform volunteer activity protocol development for ECHO. We will use...
Eligibility Criteria
Inclusion
- Inclusion/exclusion criteria (All Aims):
- Sexual and/or gender minority (SGM)-identified
- Adults (i.e., ≥ 18 years old)
- Currently smoking cigarettes
- Living in a high stigma environment in the U.S.
- Able to read English at \> 6th-grade level
- Individuals with serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler PD Scale-6 19) will be excluded from all Aims because of likelihood of functional impairments that substantially interfere with one or more major life activities.
- Aim 3 (Pilot RCT) inclusion criteria will be:
- (1) ≥ 18 years old
- (2) sexual and/or gender minority-identified (see definition above)
- (3) living in Oklahoma or one of the 8 counties in San Joaquin Valley, California (verified by address)
- (4) a current cigarette smoker (see definition above)
- (5) willing to quit smoking within 30 days of enrollment (see definition above)
- (6) own a smartphone
- (7) ability to read English at \> 6th-grade level (see definition above)
- have no NRT contraindications
- (8) ≥ weekly internet access
- (9) willing and able to participate in SGM-serving volunteer activities.
- Aim 3 (Pilot RCT) exclusion criteria: Individuals will be excluded if currently using other smoking cessation treatments.
- 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'.21 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).
- An equal number of female and male participants (i.e., natal sex) will be recruited so as to examine sex as a biological factor. Recruitment targets will aim to reflect the racial/ethnic composition of the populations from which the samples are drawn.
Exclusion
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06602076
Start Date
August 1 2026
End Date
July 1 2027
Last Update
August 19 2025
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