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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