Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain

NCT ID
NCT06983678
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Duke University
Conditions
Chronic Pain, Tobacco Use

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 132 participants (Estimated).

What is being studied

  • Behavioral: Abstinent fMRI session
  • Intervention: Manufactured Materials
  • Behavioral: Smoking as usual fMRI session
  • Intervention: Smoking Devices
  • Intervention: Technology, Industry, and Agriculture

Who may be eligible

Ages
21 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: 1. History of chronic non-cancer low back pain with duration ≥ 6 months OR no history of chronic pain; 2. age 21-65; 3. smoking of at least 10 cig/day for \> 2 years; 4. have an iPhone or Android smartphone capable of running the EMA software Exclusion Criteria: 1. pain complaint specifically due to cancer, rheumatoid arthritis, or complex regional pain syndrome; 2. actively taking steps to quit smoking; 3. inability to attend all required experimental sessions; 4. significant health problems, such as chronic hypertension, emphysema, seizure disorder, history of significant heart problems; 5. conditions that would make MRI scanning unsafe (e.g., metal implants, claustrophobia) 6. use of opioids within the past 90 days 7. past year alcohol or substance use disorder 8. positive urine test for illegal drugs (other than marijuana); 9. daily use of alcohol or marijuana; 10. lifetime history of psychotic disorder, or current unstable psychiatric disorder; 11. regular use of non-cigarette tobacco products or electronic cigarettes; 12. major surgery within the past 6 months or planned surgery within the timeframe of the study; 13. breath alcohol level \> 0.0 (participants failing for BAL will be allowed to rescreen once); 14. recently quit smoking for \> 3 days; 15. pregnancy or planning to become pregnant; 16. any factors that at the discretion of the investigators would adversely affect the participant or integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • North Carolina, United States: 1

Sample of listed locations

  • Duke North Pavilion — Durham, North Carolina, 27705, United States — Recruiting

Study details

Start date
November 4, 2025
Primary completion date
March 31, 2030
Completion date
March 31, 2030
First posted
May 21, 2025
Collaborators
National Institute on Drug Abuse (NIDA)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06983678
Registry last updated
November 20, 2025
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06983678 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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