NCT06983678 Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
| NCT ID | NCT06983678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Tobacco Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2025-11-04 with a primary completion date of 2030-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Maggie Sweitzer, Ph.D.
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06983678 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Tobacco Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06983678 currently recruiting?
Yes, NCT06983678 is actively recruiting participants. Contact the research team at sweitzerlab@duke.edu for enrollment information.
Where is the NCT06983678 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06983678 clinical trial?
NCT06983678 is sponsored by Duke University. The principal investigator is Maggie Sweitzer, Ph.D. at Duke University. The trial plans to enroll 132 participants.