Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smoking Cessation.
- Who it may be relevant to
- Registry conditions: Smoking Cessation Intervention, Pain, Smoking (Tobacco) Addiction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study
Overview
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
- Behavioral Smoking 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.
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)]
- 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)]
- 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)]
- 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)]
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)]
Eligibility 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 \[MoCA\])
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Oklahoma - Schusterman Center — Tulsa
Identifiers
NCT: NCT07080788 · 18695