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Recruiting NCT06747871

NCT06747871 Opioids, Low Nicotine Cigarettes, and Chronic Pain

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Clinical Trial Summary
NCT ID NCT06747871
Status Recruiting
Phase
Sponsor Duke University
Condition Chronic Pain
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-04-15
Primary Completion 2027-07-30

Trial Parameters

Condition Chronic Pain
Sponsor Duke University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2025-04-15
Completion 2027-07-30
Interventions
Very Low Nicotine Cigarettes (VLNC)Normal Nicotine Cigarettes (NNC)

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Brief Summary

The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).

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 suicidal

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