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 range21 Years

SexALL

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

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)

Cigarette Purchase Task - demand intensity

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

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 range21 Years

SexALL

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)

Cigarette Purchase Task - demand intensity

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