Clinical trial NCT06747871: Opioids, Low Nicotine Cigarettes, and Chronic Pain
Official title: Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Tobacco Use
Opioid Substitution Treatment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2024-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
timeFrame: Baseline and weekly during study cigarette use (4 weeks)
measure: Cigarettes per Day
timeFrame: Baseline and weekly during study cigarette use (4 weeks)
measure: Pain as measured by the Brief Pain Inventory (BPI)
timeFrame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
measure: Mechanical Hyperalgesia
timeFrame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
measure: 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)
measure: 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)
measure: Cigarette Purchase Task - demand intensity
timeFrame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
measure: Cigarette Purchase Task - Omax
timeFrame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
measure: Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)
timeFrame: Baseline, weeks 1 and 4 of study cigarette use
measure: Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency
timeFrame: Baseline, weeks 1 and 4 of study cigarette use
measure: Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving
timeFrame: Baseline, weeks 1 and 4 of study cigarette use
measure: Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)
timeFrame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Secondary outcomes:
measure: Number of participants willing to Quit Smoking
timeFrame: post-intervention, after 24 hrs abstinence
measure: Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ)
timeFrame: Weekly visits 1 and 5
measure: Pain and Smoking Inventory (PSI)
timeFrame: Weekly visits 1 and 5
measure: Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT)
timeFrame: Weekly visits 1 and 5
Other outcomes:
Locations:
city: Durham
country: United States
facility: North Pavilion
state: North Carolina
Study officials:
affiliation: Duke University
name: Maggie Sweitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: