Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain
Sponsor study identifier
Secondary identifiers
interventional
60
1 country
1
Study Start
April 15, 2025
Actual (reported)Primary Completion
July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2024
Actual (reported)December 24, 2024
Actual (reported)April 15, 2025
Actual (reported)July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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
Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.
Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.
Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.
Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.
North Pavilion
Durham, North Carolina, 27705, United States
Maggie Sweitzer, PhD
Duke University
First Submitted
December 16, 2024
First Posted
December 24, 2024
Study Start
April 15, 2025
Actual (reported)Primary Completion
July 30, 2027
EstimatedOral Nicotine Pouch Marketing Features Influence on Perceptions
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)
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Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 9, 2026
Record last verified: 2026-01
The final dataset will include demographic, interview and self-report data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures will be used for data de-identification and sharing, and informed consent will reflect those plans.
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Source: ClinicalTrials.gov.
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