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Recruiting NCT06747871

Opioids, Low Nicotine Cigarettes, and Chronic Pain

No phase Interventional Chronic Pain Tobacco Use Opioid Substitution Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Very Low Nicotine Cigarettes (VLNC), Normal Nicotine Cigarettes (NNC).
Who it may be relevant to
Registry conditions: Chronic Pain, Tobacco Use, Opioid Substitution Treatment. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD) [Time frame: Baseline and weekly during study cigarette use (4 weeks)]
  • Cigarettes per Day [Time frame: Baseline and weekly during study cigarette use (4 weeks)]
  • Pain as measured by the Brief Pain Inventory (BPI) [Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)]
  • Mechanical Hyperalgesia [Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions]
  • Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS) [Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)]
  • Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B) [Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)]
  • Cigarette Purchase Task - demand intensity [Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions]
  • Cigarette Purchase Task - Omax [Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions]
  • Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA) [Time frame: Baseline, weeks 1 and 4 of study cigarette use]
  • Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency [Time frame: Baseline, weeks 1 and 4 of study cigarette use]
Secondary outcome measures (4)
  • Number of participants willing to Quit Smoking [Time frame: post-intervention, after 24 hrs abstinence]
  • Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ) [Time frame: Weekly visits 1 and 5]
  • Pain and Smoking Inventory (PSI) [Time frame: Weekly visits 1 and 5]
  • Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT) [Time frame: Weekly visits 1 and 5]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • North Pavilion — Durham

Identifiers

NCT: NCT06747871 · Pro00116478 · 1R34DA060477-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗