RecruitingNot Applicable

Opioids, Low Nicotine Cigarettes, and Chronic Pain

United States60 participantsStarted 2025-04-15

Plain-language 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).

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Cigarettes per Day

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

Pain as measured by the Brief Pain Inventory (BPI)

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

Mechanical Hyperalgesia

Timeframe: 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)

Timeframe: 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)

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

Trial details

NCT IDNCT06747871

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Clinical Research Coordinator

919-907-9955 ta141@duke.edu

View on ClinicalTrials.gov More Chronic Pain trials

Plain-language summary

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

Cigarettes per Day

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

Pain as measured by the Brief Pain Inventory (BPI)

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

Mechanical Hyperalgesia

Timeframe: 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)

Timeframe: 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)

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