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NCT Number: NCT07080788

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

smoking cessation

Behavioral

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.

Primary outcomes

  1. Pain inhibition

    Time frame: Baseline (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.

  2. Inhibition of pain-related spinal reflex

    Time frame: Baseline (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.

  3. Allostatic load

    Time frame: Baseline (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.

  4. Pain amplification

    Time frame: 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 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 outcomes

  1. Temporal summation of pain

    Time frame: Baseline (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie L Rhudy, PhD

CONTACT

[email protected]

918-660-3050

PLAN Lab

CONTACT

[email protected]

918-660-3048

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: OK-SNAPIV

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 23, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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