Opioids, Low Nicotine Cigarettes, and Chronic Pain

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06747871
Status
Recruiting
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Conditions

  • Chronic Pain
  • Opioid Substitution Treatment
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Very Low Nicotine Cigarettes (VLNC) — BEHAVIORAL
    Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.
  • Normal Nicotine Cigarettes (NNC) — BEHAVIORAL
    Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.

Study Details

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).

Key Dates

Start date
Apr 15, 2025
Status verified
Jan 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Very Low Nicotine Cigarette (VLNC) Group
    Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.
  • Active Comparator: Normal Nicotine Cigarette (NNC) Group
    Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Primary Outcome Measure

Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD) [ Time Frame: Baseline and weekly during study cigarette use (4 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
North PavilionDurhamNorth Carolina27705
Clinical Research Coordinator
[email protected]
919-907-9955

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By research site
North Pavilion· Durham, NC

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