Opioids, Low Nicotine Cigarettes, and Chronic Pain Study
This study is looking at how switching to very low nicotine cigarettes (Spectrum NRC 102/103) or normal nicotine cigarettes (Spectrum NRC 600/601) affects craving, withdrawal, and pain. You might be able to join if you are at least 21 years old, smoke cigarettes daily, have chronic non-cancer musculoskeletal pain, and have been on buprenorphine treatment for opioid use disorder for at least 30 days. The study will look at how much nicotine dependence you have, how many cigarettes you smoke each day, and your pain levels. The study is currently unclear about its recruitment status and plans to enroll 60 participants.
- Study design
- This is an interventional study that plans to enroll 60 participants. It compares two types of cigarettes: very low nicotine and normal nicotine.
- What's involved
- You would have weekly visits during the 4 weeks of using study cigarettes. Your nicotine dependence, cigarette use, and pain levels will be measured at baseline and throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your nicotine dependence, cigarette use, and pain levels will be measured weekly during the 4 weeks of study cigarette use.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Opioids, Low Nicotine Cigarettes, and Chronic Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maggie Sweitzer, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)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.
- Cigarettes per DayBaseline 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
- Pain as measured by the Brief Pain Inventory (BPI)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.
- Mechanical HyperalgesiaWeekly 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.
- Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS)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.
- Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B)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.
- Cigarette Purchase Task - demand intensityWeekly 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).
- Cigarette Purchase Task - OmaxWeekly 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).
- Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)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.
- Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequencyBaseline, weeks 1 and 4 of study cigarette use
Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.
- Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - cravingBaseline, weeks 1 and 4 of study cigarette use
Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.
- Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)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.