Developing Empowering Smoking Cessation

NCT06602076 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: 175831R34DA060534-01A1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 relapse within 6 months of a quit attempt. Existing smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than socioenvironmental influences on cessation success. Cessation interventions based on evidence linking social stress to increased nicotine dependence and relapse risk are needed to address the stressors people who smoke encounter while navigating their social environments (i.e., social stress). Effective empowering approaches for infectious disease prevention and youth tobacco use suggest that Empowerment Theory may also enhance smoking cessation assistance for people experiencing high levels of social stress. Hypothesis: Our hypothesis is that when people participate in community-serving volunteer activities, they may also experience cognitive and behavioral changes (i.e., enhanced stress coping, social support, self-worth, prosociality) that ameliorate the effects of social stress, thereby supporting smoking cessation. Importance: Empowerment Theory-informed health behavior change approaches have worked for infectious disease prevention and youth tobacco interventions. Our pretest (N=20; Oklahoma) demonstrated the feasibility and acceptability of volunteer activity participation as an adjunct to standard smoking cessation treatment. This novel smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community engagement. To ensure scalability and accessibility of this remotely delivered intervention, we will utilize the NIH-supported Dissemination and Implementation (D\&I) science framework, the Practical, Robust Implementation and Sustainability Model (PRISM), which is the contextually expanded version of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance). This project will advance efforts to understand and address high tobacco use among people experiencing high levels of social stress and will inform a future R01 application for a fully-powered, multi-site RCT of ECHO aiming to end tobacco use across the U.S. while supporting community connectedness.

Conditions

Smoking Cessation

Keywords

tobacco use; smoking cessation; stress; social support; community engaged

Outcome Measures

Primary Outcomes (4)

• Retention

  BENCHMARK: Retention at week 12 (minimum 80%)

  12 weeks

• Intervention feasibility

  The following post-intervention outcome will be assessed at Week 12: Overall intervention feasibility will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater feasibility. BENCHMARK: Intervention feasibility at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).

  12 weeks

• Intervention acceptability

  The following post-intervention outcome will be assessed at Week 12: Overall intervention acceptability will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater acceptability. BENCHMARK: Intervention acceptability at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).

  12 weeks

• Intervention appropriateness

  The following post-intervention outcome will be assessed at Week 12: Overall intervention appropriateness will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater appropriateness. BENCHMARK: Intervention appropriateness at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).

  12 weeks

Secondary Outcomes (5)

• Self-reported smoking abstinence assessed at Week 12

  12 weeks

• Self-efficacy asssessed at Week 12

  12 weeks

• Motivation to quit smoking assessed at Week 12

  12 weeks

• Smoking intensity assessed at Week 12

  12 weeks

• Cessation Treatment Engagement assessed at Week 12

  12 weeks

Other Outcomes (4)

• Self-reported smoking abstinence assessed at Week 24

  24 weeks

• Smoking intensity assessed at Week 24

  24 weeks

• Motivation to quit smoking assessed at Week 24

  24 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Receive standard smoking cessation treatment in the form of the NCI's quitSTART smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail, plus participate in online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites.

Behavioral: ECHO (Empowering Our Community & Health Outcomes)

Control

NO INTERVENTION

Receive standard smoking cessation treatment in the form of the NCI's quitSTART smoking cessation smartphone app and free over-the-counter nicotine replacement therapy provided by mail.

Interventions

ECHO (Empowering Our Community & Health Outcomes) BEHAVIORAL

Additive intervention design wherein study participants receive remotely-delivered standard smoking cessation support (i.e., behavioral support plus nicotine replacement therapy) and engage in community-serving volunteer activities.

Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• (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

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Julia M McQuoid, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia M McQuoid, PhD

CONTACT

(405) 271-6872; julia-mcquoid@ouhsc.edu

Jan Foisy

CONTACT

(405) 271-6872; jan-foisy@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding participants will not be possible because participants will be able to tell if they are in the treatment group versus control group due to the volunteer activities in the treatment group and absence of such activities in the control group. Investigators will remain blinded to the group assignments. Randomization will use a centralized and automated system to ensure allocation concealment from outcomes analysts. If manual allocation is required, sequentially numbered, opaque, sealed envelopes will be utilized to maintain allocation concealment and managed internally at OU. Additionally, the following blinded outcome assessment procedures are planned: Outcome assessors will be a separate and unique team from those managing allocation and tracking of participants during the research activities; Participants will be assigned unique codes that do not reveal their identity and group to the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a 2-arm, 12-week pilot randomized controlled trial (RCT) with Week 24 follow up, N=50 adults willing to quit smoking from Oklahoma (OK) and the San Joaquin Valley (SJV) in California will be randomized to receive either the NCI's quitSTART smoking cessation smartphone app and free nicotine replacement therapy (NRT; control, n=25), or quitSTART and NRT plus ECHO, which includes online community-serving volunteer activities (≥4 sessions) and a digital hub (Reddit) to foster social support across sites.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available as soon as possible or (at the latest) at the time of associated publication. The duration of preservation and sharing of the data will be a minimum of five years after the end of the funding period but is anticipated to continue in perpetuity.
• Access Criteria: Access to data will be controlled as restricted-use. Given the sensitive information (I.e., enables the potential identification of respondents from rural settings through inference) the dataset, de-identified individual participant-level data will be made available in the ICPSR repository, which restricts access to qualified investigators with an appropriate research question who sign a data use agreement and undergo an approval process.