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Search / Trial NCT06747871

Opioids, Low Nicotine Cigarettes, and Chronic Pain

Launched by DUKE UNIVERSITY · Dec 20, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how switching from regular cigarettes to very low nicotine content (VLNC) cigarettes affects people with chronic pain who smoke every day. The study aims to understand how this change impacts cravings for cigarettes, withdrawal symptoms, and pain levels among those who are already receiving treatment for opioid use disorder. Participants will be monitored while they try this new type of cigarette to see if it helps them manage both their smoking and pain better.

To be eligible for this study, participants need to be at least 21 years old, smoke at least 10 cigarettes a day, and have chronic pain from conditions like low back pain or osteoarthritis. They must also be receiving stable treatment for opioid use disorder for at least 30 days. Participants will need a smartphone to help with tracking their experiences during the study. It’s important to note that this trial is not currently recruiting, so anyone interested will need to wait until it begins.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 21+ years who smoke cigarettes daily
  • Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
  • Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
  • Self-report smoking at least 10 cigarettes/day
  • Expired breath carbon monoxide (CO) level \>8 ppm
  • Have a smartphone capable of running software for ecological momentary assessment
  • Open to exploring the possibility of quitting smoking
  • Exclusion Criteria:
  • Pain specifically due to cancer
  • Other significant health problems
  • Major surgery within the past 6 months or planned surgery within the timeframe of the study
  • Current disability litigation
  • Use of electronic cigarettes or other non-cigarette tobacco products \> 9 of the past 30 days
  • Current use of nicotine replacement therapy or other cessation treatment
  • Current daily or near-daily cannabis use
  • History of psychotic disorder
  • Acute suicidality or current unstable psychiatric disorder
  • Positive pregnancy test
  • Actively seeking smoking cessation treatment

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

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Maggie Sweitzer, PhD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported