Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-identify as Native American/American Indian
Currently daily smoker
Own a smartphone with a data plan
Ability to speak and read English
Disqualifiers
>18 years of age
Currently pregnant
Self-reported history of heart disease or heart attack
Angina, arrhythmias, hypertension, heart disease
Trial design
Design model
Single group
Treatments tested in this trial
Smoking Cessation
BehavioralInvestigators 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 groups
150 Participants
are divided into 1 treatment groupGroup A: Smoking CessationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain inhibition
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.
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)2
Inhibition of pain-related spinal reflex
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.
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)3
Allostatic load
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.
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)4
Pain amplification
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.
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 outcomes
1
Temporal summation of pain
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.
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)Sponsors and contacts
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Source ClinicalTrials.gov