Effects of Low Nicotine Cigarettes on Chronic Pain and Cravings
Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain
This study tests if switching to very low nicotine cigarettes can help people with chronic pain who smoke and are being treated for opioid addiction by reducing their cravings and pain levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06747871 on ClinicalTrials.gov |
What this trial studies
This study evaluates how switching from normal nicotine content cigarettes to very low nicotine content cigarettes affects cravings, withdrawal symptoms, and pain levels in individuals with chronic pain who smoke daily and are undergoing buprenorphine treatment for opioid use disorder. Participants will be monitored for changes in their pain and smoking behaviors over the course of the intervention. The study aims to provide insights into the potential benefits of reducing nicotine intake for managing chronic pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who smoke at least 10 cigarettes daily and have chronic non-cancer musculoskeletal pain.
Not a fit: Patients with cancer-related pain or significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients with chronic pain reduce their nicotine dependence while managing their pain more effectively.
How similar studies have performed: Other studies have shown promise in using low nicotine cigarettes to aid smoking cessation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- North Pavilion — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Maggie Sweitzer, PhD — Duke University
- Study coordinator: Clinical Research Coordinator
- Email: ta141@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.