Status:
RECRUITING
Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use
Chronic Pain
Eligibility:
All Genders
21-65 years
Phase:
NA
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 i...
Detailed Description
Eligible participants will complete an initial in-person screening session in which eligibility is confirmed and baseline pain and smoking measures are collected, followed by a sensory testing and tra...
Eligibility Criteria
Inclusion
- History of chronic non-cancer low back pain with duration ≥ 6 months OR no history of chronic pain;
- age 21-65;
- smoking of at least 10 cig/day for \> 2 years;
- have an iPhone or Android smartphone capable of running the EMA software
Exclusion
- pain complaint specifically due to cancer, rheumatoid arthritis, or complex regional pain syndrome;
- actively taking steps to quit smoking;
- inability to attend all required experimental sessions;
- significant health problems, such as chronic hypertension, emphysema, seizure disorder, history of significant heart problems;
- conditions that would make MRI scanning unsafe (e.g., metal implants, claustrophobia)
- use of opioids within the past 90 days
- past year alcohol or substance use disorder
- positive urine test for illegal drugs (other than marijuana);
- daily use of alcohol or marijuana;
- lifetime history of psychotic disorder, or current unstable psychiatric disorder;
- regular use of non-cigarette tobacco products or electronic cigarettes;
- major surgery within the past 6 months or planned surgery within the timeframe of the study;
- breath alcohol level \> 0.0 (participants failing for BAL will be allowed to rescreen once);
- recently quit smoking for \> 3 days;
- pregnancy or planning to become pregnant;
- 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)
Key Trial Info
Start Date :
November 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06983678
Start Date
November 4 2025
End Date
March 31 2030
Last Update
November 20 2025
Active Locations (1)
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1
Duke North Pavilion
Durham, North Carolina, United States, 27705