Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain

NCT ID: NCT07080788

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-06-30

Brief Summary

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.

Conditions

Smoking Cessation Intervention; Pain; Smoking (Tobacco) Addiction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Smoking Cessation

Group Type: EXPERIMENTAL

Smoking Cessation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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])

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie L Rhudy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Sciences

Locations

University of Oklahoma - Schusterman Center

Tulsa, Oklahoma, United States

Countries

United States

Central Contacts

PLAN Lab

Role: CONTACT

tulsa.plan@gmail.com

918-660-3048

Jamie L Rhudy, PhD

Role: CONTACT

jamie-rhudy@ouhsc.edu

918-660-3050

Facility Contacts

PLAN Lab

Role: primary

tulsa.plan@gmail.com

918-660-3048

Jamie L Rhudy, PhD

Role: backup

jamie-rhudy@ouhsc.edu

918-660-3050

Other Identifiers

18695

Identifier Type: -

Identifier Source: org_study_id