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Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain

Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07080788
Acronym
OK-SNAPIV
Enrollment
150
Registered
2025-07-23
Start date
2025-09-01
Completion date
2028-06-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Smoking Cessation Intervention, Smoking (Tobacco) Addiction

Keywords

Smoking cessation, Quantitative sensory testing

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.

Detailed description

Native Americans experience the highest rates of chronic pain of all U.S. racial/ethnic groups, and we have shown this disparity is partly explained by disrupted physiological pain regulation mechanisms, i.e., enhanced pain amplification and impaired pain inhibition. One unexplored variable that could disrupt these mechanisms in Native Americans is non-ceremonial tobacco smoking. Native Americans have the highest smoking rate in the U.S., and smoking is associated with disrupted pain regulation in non-Native American samples. Thus, there is a critical need to understand whether smoking contributes to NA pain risk. There is high comorbidity between smoking and chronic pain, but it is also known that chronic pain patients who quit smoking have improved pain. This study aims to better understand the relationship between Native American smoking and chronic pain risk. It is believed that smoking increases chronic pain risk in pain-free Native Americans by increasing pain amplification and impairing pain inhibition, and smoking abstinence will reduce pain amplification and increase pain inhibition.

Interventions

BEHAVIORALSmoking Cessation

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.

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 \[MoCA\])

Design outcomes

Primary

MeasureTime frameDescription
Pain inhibitionBaseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)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.
Inhibition of pain-related spinal reflexBaseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)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.
Allostatic loadBaseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)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.
Pain amplificationBaseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)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.

Secondary

MeasureTime frameDescription
Temporal summation of painBaseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)Temporal summation of pain will be measured by assessing the change in a participant's pain ratings in response to identical noxious stimuli delivered in a rapid succession.

Countries

United States

Contacts

CONTACTPLAN Lab
tulsa.plan@gmail.com918-660-3048
CONTACTJamie L Rhudy, PhD
jamie-rhudy@ouhsc.edu918-660-3050
PRINCIPAL_INVESTIGATORJamie L Rhudy, PhD

University of Oklahoma Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026