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NCT Number: NCT06747871

Opioids, Low Nicotine Cigarettes, and Chronic Pain

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).

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Key information

Conditions

Chronic Pain Behavior Neurologic Manifestations Opioid Substitution Treatment Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tobacco Use

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Pavilion

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Clinical Research Coordinator

CONTACT

[email protected]

919-907-9955

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)

    Time frame: Baseline and weekly during study cigarette use (4 weeks)

    The FTCD has a total score of 0 to 10, where a greater score indicates a greater physical dependence on nicotine.

  2. Cigarettes per Day

    Time frame: Baseline and weekly during study cigarette use (4 weeks)

    Average cigarettes smoked per day during the past week will be calculated using timeline follow-back methods

  3. 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)

    The BPI has an averaged score of 0 to 10, where a greater score indicates greater pain.

  4. Mechanical Hyperalgesia

    Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions

    Mechanical hyperalgesia is a condition that causes increased sensitivity to mechanical stimuli after an injury to the skin. Discriminability and response bias will be assessed using a computerized pressure algometer.

  5. 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)

    The MNWS has a total score range of 0 to 68, where a higher score indicates greater symptoms of withdrawal.

  6. 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)

    The QSU-B has a total score range of 0 to 100, where a higher score indicates greater craving.

  7. Cigarette Purchase Task - demand intensity

    Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions

    Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).

  8. Cigarette Purchase Task - Omax

    Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions

    Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).

  9. Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)

    Time frame: Baseline, weeks 1 and 4 of study cigarette use

    EMA (also called experience sampling or daily diary method) involves repeated sampling of people's current experiences (e.g. pain) in real time in their natural environments.

  10. Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency

    Time frame: Baseline, weeks 1 and 4 of study cigarette use

    Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.

  11. Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving

    Time frame: Baseline, weeks 1 and 4 of study cigarette use

    Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.

  12. Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)

    Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)

    The SOWS consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0-not at all, 1-a little, 2-moderately, 3-quite a bit, 4-extremely. The total score ranges from 0 to 64, where a higher score indicates greater symptoms of withdrawal.

Secondary outcomes

  1. Number of participants willing to Quit Smoking

    Time frame: post-intervention, after 24 hrs abstinence

    Decision (yes/no) to engage in the optional quit attempt

  2. Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ)

    Time frame: Weekly visits 1 and 5

    The SEQ has a total score range of 10 to 40, where a higher score indicates greater self-efficacy.

  3. Pain and Smoking Inventory (PSI)

    Time frame: Weekly visits 1 and 5

    The PSI total score is computed by averaging scores across the nine items. Items are endorsed on a seven-point Likert scale anchored at 0 (not true at all), 3 (somewhat true), and 6 (extremely true). Scores range from 0 to 6, where higher scores indicate greater perceptions that pain and smoking are interrelated.

  4. Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT)

    Time frame: Weekly visits 1 and 5

    The BQS-SAT is an 11-item true-false instrument of perceived barriers to quitting smoking plus one open-ended item. The score can range from 0 to 4.86, where a higher score indicates a greater perceived barrier.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coordinator

CONTACT

[email protected]

919-907-9955

Clinical Research Coordinator

CONTACT

[email protected]

984-327-6157

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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