How short-term smoking abstinence changes brain pain processing in people who smoke with or without chronic low back pain
Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
This will test whether 24-hour smoking abstinence increases pain sensitivity in the brain and makes quitting harder for adults who smoke, including those with chronic low back pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06983678 on ClinicalTrials.gov |
What this trial studies
Adults who smoke (with chronic non-cancer low back pain or without chronic pain) will complete sensory training and two fMRI sessions in a within-subject crossover design: one after 24 hours of abstinence and one after smoking as usual. During each scan participants receive painful heat stimuli and provide pain ratings while craving, withdrawal, and physiological measures are recorded. After scanning participants install EMA software on their smartphone, complete baseline ecological momentary assessments, and then attempt to abstain while continuing EMA with biochemical verification. The study compares brain activation and behavioral responses across smoking and abstinent conditions to see if withdrawal-induced hyperalgesia interferes with quit attempts.
Who should consider this trial
Good fit: Adults aged 21–65 who smoke at least 10 cigarettes per day for over 2 years and either have chronic non-cancer low back pain for ≥6 months or no chronic pain, who can undergo MRI and use a smartphone for EMA.
Not a fit: People actively trying to quit, those using opioids, with MRI contraindications, significant uncontrolled medical or recent substance use disorders, or other exclusionary conditions would likely be ineligible and may not benefit from participation.
Why it matters
Potential benefit: If successful, the results could inform targeted interventions to help people with chronic pain who smoke to quit and better manage pain.
How similar studies have performed: Prior studies show nicotine withdrawal can increase pain and fMRI research has mapped pain-related brain responses, but applying these methods specifically to withdrawal-induced hyperalgesia in chronic pain populations combined with real-world EMA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Durham, North Carolina
- Duke North Pavilion — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Maggie Sweitzer, Ph.D. — Duke University
- Study coordinator: Clinical Research Coordinator
- Email: sweitzerlab@duke.edu
- Phone: 919-907-9955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.