Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain (OK-SNAP IV)

University of Oklahoma (OU)

Status: Begins enrollment this month

Conditions: Smoking (Tobacco) Addiction; Smoking Cessation Intervention; Pain

Treatments: Behavioral: Smoking Cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT07080788

18695

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• >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])

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Smoking Cessation

Experimental group

Treatment:

Behavioral: Smoking Cessation