Oklahoma Native American smoking cessation and pain risk IV
Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study
This pilot will try 4 weeks of verified smoking abstinence with financial incentives to see if it lowers physiological signs of chronic pain risk in adult Native American daily smokers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Tulsa, Oklahoma) |
| Trial ID | NCT07080788 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study enrolls adult self-identified Native American daily smokers without current chronic pain and uses financial incentives to support smoking cessation. Participants who achieve verified 4-week abstinence will undergo quantitative sensory testing to measure pain amplification and pain inhibition, compared with non-abstinent participants. The study is designed to determine feasibility and to estimate effect sizes for changes in pain regulation and for variables in a conceptual model linking smoking to pain risk in this population. All visits take place at the University of Oklahoma Schusterman Center in Tulsa and require a smartphone for study procedures and monitoring.
Who should consider this trial
Good fit: Ideal candidates are adult self-identified Native American daily smokers who do not have current chronic pain, can speak and read English, own a smartphone with a data plan, and meet safety criteria (not pregnant, no serious heart disease, no psychosis or significant cognitive impairment).
Not a fit: People with current chronic pain, pregnant individuals, those with significant heart disease, active psychosis, or serious cognitive impairment are excluded and therefore unlikely to benefit from this pilot's findings.
Why it matters
Potential benefit: If successful, quitting smoking could reduce pain amplification and improve pain inhibition, potentially lowering long-term chronic pain risk among Native American smokers.
How similar studies have performed: Prior work in non-Native populations links smoking to disrupted pain regulation and shows pain can improve after quitting, but testing these mechanisms specifically in Native American smokers is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self-identify as Native American/American Indian * Currently daily smoker * Own a smartphone with a data plan * Ability to speak and read English Exclusion Criteria: * \>18 years of age * Currently pregnant * Self-reported history of heart disease or heart attack * Angina, arrhythmias, hypertension, heart disease * Current chronic pain * Pepper allergy * Inability to speak English * Current psychosis (assessed by Psychosis Screening Questionnaire) * Serious cognitive impairment (assessed by \<20 score on the Montreal Cognitive Assessment \[MoCA\])
Where this trial is running
Tulsa, Oklahoma
- University of Oklahoma - Schusterman Center — Tulsa, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Jamie L Rhudy, PhD — University of Oklahoma Health Sciences
- Study coordinator: PLAN Lab
- Email: tulsa.plan@gmail.com
- Phone: 918-660-3048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.