Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Pain inhibition
研究概览
简要总结
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:
- Determine study feasibility.
- Obtain effect sizes for changes in pain amplification and pain inhibition in abstinent vs non-abstinent Native Americans.
- Obtain effect sizes for variables in the conceptual model of the Native American smoking-pain relationship.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identify as Native American/American Indian
- •Currently smoking > 10 cigarettes per day but interested in quitting
- •Own a smartphone with a data plan
- •Ability to speak and read English
排除标准
- •>18 years of age
- •Currently pregnant
- •Self-reported history of cardiovascular, neuroendocrine, musculoskeletal, or neurological disorders
- •Current chronic pain
- •Use of medication that could interfere with testing (e.g., recent use of analgesics, antidepressants, or anti-anxiety medications)
- •Pepper allergy
- •Inability to speak English
- •Angina, arrhythmias, hypertension, heart disease
- •Current psychosis (assessed by Psychosis Screening Questionnaire)
- •Serious cognitive impairment (assessed by <20 score on the Montreal Cognitive Assessment [MoCA])
结局指标
主要结局
Pain inhibition
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))