RecruitingNot ApplicableNCT06747871

Opioids, Low Nicotine Cigarettes, and Chronic Pain

Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain


Sponsor

Duke University

Enrollment

60 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 Years

Inclusion Criteria7

  • 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 Criteria11

  • 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

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Interventions

BEHAVIORALVery Low Nicotine Cigarettes (VLNC)

Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.

BEHAVIORALNormal Nicotine Cigarettes (NNC)

Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.


Locations(1)

North Pavilion

Durham, North Carolina, United States

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NCT06747871


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