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

RecruitingNAAges 21 Years - 65 YearsAllDuke University
NCT06983678 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Individuals with chronic pain are more likely to smoke cigarettes and have more difficulty quitting smoking than the general population, in part because withdrawal from smoking can lead to temporary increases in pain. This research will examine how smoking withdrawal changes the way the brain processes pain, and whether these withdrawal-related changes interfere with the ability to stop smoking. The results of this research will provide important information that can be used to guide the development of interventions to help people with chronic pain who smoke cigarettes to quit smoking and improve their health.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Smoking as usual fMRI session
  • Abstinent fMRI session
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Where

1 site
Duke North Pavilion
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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