Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain
ID: NCT07080788
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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.
Read Full Scientific Objectives & Methods
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.
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.
Treatment Arms Description
- Self-identify as Native American/American Indian
- Currently daily smoker
- Own a smartphone with a data plan
- Ability to speak and read English
- \>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 \[MoCA\])
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
View Secondary Outcome Measures (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.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study