Opioids, Low Nicotine Cigarettes, and Chronic Pain

NCT06747871 | Recruiting

• 2 other identifiers: Pro001164781R34DA060477-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain; Tobacco Use; Opioid Substitution Treatment

Outcome Measures

Primary Outcomes (12)

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

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

  Baseline and weekly during study cigarette use (4 weeks)

• Cigarettes per Day

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

  Baseline and weekly during study cigarette use (4 weeks)

• Pain as measured by the Brief Pain Inventory (BPI)

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

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

• Mechanical Hyperalgesia

  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.

  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)

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

  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)

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

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

• Cigarette Purchase Task - demand intensity

  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).

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

• Cigarette Purchase Task - Omax

  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).

  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)

  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.

  Baseline, weeks 1 and 4 of study cigarette use

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

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

  Baseline, weeks 1 and 4 of study cigarette use

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

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

  Baseline, weeks 1 and 4 of study cigarette use

• Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)

  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.

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

Secondary Outcomes (4)

• Number of participants willing to Quit Smoking

  post-intervention, after 24 hrs abstinence

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

  Weekly visits 1 and 5

• Pain and Smoking Inventory (PSI)

  Weekly visits 1 and 5

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

  Weekly visits 1 and 5

Study Arms (2)

Very Low Nicotine Cigarette (VLNC) Group

EXPERIMENTAL

Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Behavioral: Very Low Nicotine Cigarettes (VLNC)

Normal Nicotine Cigarette (NNC) Group

ACTIVE COMPARATOR

Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Behavioral: Normal Nicotine Cigarettes (NNC)

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.

Very Low Nicotine Cigarette (VLNC) Group

Normal Nicotine Cigarettes (NNC) BEHAVIORAL

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

Normal Nicotine Cigarette (NNC) Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

North Pavilion

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Tobacco Use

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Maggie Sweitzer, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

919-907-9955; ta141@duke.edu

Clinical Research Coordinator

CONTACT

984-327-6157; lgf12@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)