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Search / Trial NCT06983678

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

Launched by DUKE UNIVERSITY · May 14, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how quitting smoking affects people with chronic pain, especially focusing on how withdrawal from smoking might make pain feel worse. Researchers want to understand how the brain reacts to pain during this withdrawal period and whether these changes make it harder for individuals to stop smoking. The goal is to gather insights that can help develop better support and treatment for people who have chronic pain and want to quit smoking, ultimately leading to improved health.

To participate in this study, individuals should be between the ages of 21 and 65, have a history of chronic low back pain lasting at least six months or no chronic pain at all, and have been smoking at least 10 cigarettes a day for over two years. Participants will need to use a smartphone with specific software for the study and be able to attend all required sessions. It's important to note that certain health conditions and recent substance use may disqualify potential participants. This trial is not yet recruiting, but it aims to help those who smoke and deal with chronic pain by finding effective ways to assist them in quitting.

Gender

ALL

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)

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Patients applied

0 patients applied

Trial Officials

Maggie Sweitzer, Ph.D.

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported