Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain
OK-SNAPIV
Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study
1 other identifier
interventional
150
1 country
1
Brief Summary
The goal of this pilot study is to assess whether 4-weeks of verified smoking abstinence following financial incentive treatment for smoking cessation improves physiological markers of chronic pain risk in adult Native American smokers. The main aims to answer are:
- 1.Determine study feasibility.
- 2.Obtain effect sizes for changes in pain amplification and pain inhibition in abstinent vs non-abstinent Native Americans.
- 3.Obtain effect sizes for variables in the conceptual model of the Native American smoking-pain relationship.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
March 2, 2026
February 1, 2026
1.7 years
July 3, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pain inhibition
Pain inhibition will be assessed using a conditioned pain modulation task with cold water as the conditioning stimulus and electric stimulations as the test stimulus.
Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)
Inhibition of pain-related spinal reflex
Pain-related spinal reflex inhibition assessed from electromyogram will be assessed using a conditioned pain modulation task with cold water as the conditioning stimulus and electric stimulations as the test stimulus.
Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)
Allostatic load
A single latent variable for allostatic load will be created using principal components analysis to combine cardiovascular (i.e., resting blood pressure and heart rate and fasting lipid profile \[HDL, LDL, total cholesterol, and triglycerides\]), metabolic (i.e., BMI, waist-to-hip ratio, HbA1c), immune (i.e., hs-CRP), and parasympathetic (i.e., resting heart rate variability) variables.
Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)
Pain amplification
Pain amplification will be assessed by capsaicin (substance from hot chili peppers) pain model. Pain amplification is defined as the area of skin (in cm squared) surrounding the site of capsaicin application that shows higher pain relative to the untreated skin.
Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)
Secondary Outcomes (1)
Temporal summation of pain
Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)
Study Arms (1)
Smoking Cessation
EXPERIMENTALInterventions
Investigators will provide financial incentives for biochemically verified abstinence at 4 weeks following treatment. This incentive is consistent with recent research using macro-level financial incentives and incorporates both short-term and long-term incentives to shape behavior.
Eligibility Criteria
You may qualify if:
- Self-identify as Native American/American Indian
- Currently daily smoker
- Own a smartphone with a data plan
- Ability to speak and read English
You may not qualify if:
- \>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 \[MoCA\])
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma - Schusterman Center
Tulsa, Oklahoma, 74135, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie L Rhudy, PhD
University of Oklahoma Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2025
First Posted
July 23, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- De-identified data will become available following publication of all findings (around 6/1/2030)
- Access Criteria
- To obtain access to the data, interested parties can contact the PI (jamie-rhudy@ouhsc.edu
Data and metadata will reside with the PI, research team, and tribal partners and made available to others following review, by the PI and tribal IRBs, of the data request. Requests for data will be made available as soon as possible, but no later than time of an associated publication. Those investigators approved to use data will be instructed to submit any products for tribal IRB review and approval before they are submitted for publication or presentation. If the goals of the approved request are outside the aims of the parent project, the requesting investigators may be required to reconsent participants before they are allowed access to data.