NCT06983678|Recruiting
Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
PRISM02
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PRISM02
Sponsor study identifier
Secondary identifiers
interventional
132
1 country
1
Study Start
November 4, 2025
Actual (reported)Primary Completion
March 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Individuals with chronic pain are more likely to smoke cigarettes and have more difficulty quitting smoking than the general population, in part because withdrawal from smoking can lead to temporary increases in pain. This research will examine how smoking withdrawal changes the way the brain processes pain, and whether these withdrawal-related changes interfere with the ability to stop smoking. The results of this research will provide important information that can be used to guide the development of interventions to help people with chronic pain who smoke cigarettes to quit smoking and improve their health.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2030
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.
May 14, 2025
Actual (reported)May 21, 2025
Actual (reported)November 4, 2025
Actual (reported)March 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Pain intensity ratings to high heat vs neutral temperatures
Participants will rate their current pain intensity following each of the heat stimulus blocks during the fMRI scans. Pain intensity is measured on a 0-10 visual analogue scale, with higher scores indicating greater pain.
Measured at each fMRI session (up to 1.5 hours)
Activation of the inferior frontal gyrus (IFG)
% signal change in response to the contrast of high heat vs rest will be extracted from right and left IFG
Measured at each fMRI session (up to 1.5 hours)
Resting state functional connectivity with the IFG
Fisher-Z transformed correlation maps of connectivity with the IFG will be evaluated within a subcortical mask including the caudate and thalamus
Measured at each fMRI session (up to 1.5 hours)
Time to lapse
The number of days of continuous, biochemically verified abstinence prior to smoking
Measured daily during the 1-week abstinence test
Daily pain ratings
Mean pain ratings during the initial days of abstinence will be examined as a function of chronic pain status, assessed at baseline
Participants with chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session.
Participants with chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session.
Participants in this condition will continue smoking as usual prior to the fMRI session
Duke North Pavilion
Durham, North Carolina, 27705, United States
Maggie Sweitzer, Ph.D.
Duke University
First Submitted
May 14, 2025
First Posted
May 21, 2025
Study Start
November 4, 2025
Actual (reported)Primary Completion
March 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Remote Trial - Tobacco Product Standard (VLNC)
Measured with daily EMA prompts for 10 days
Daily withdrawal symptoms
Daily withdrawal symptoms will be assessed over EMA using the Minnesota Smoking Withdrawal Scale. Mean withdrawal symptoms during the initial days of abstinence will be examined as a function of chronic pain status, assessed at baseline
Measured with daily EMA prompts for 10 days
Fluctuations in pain ratings vs smoking urge
Fluctuations in pain ratings will be examined to determine their association with level of smoking urge
Measured 5 times per day with random EMA prompts for 10 days
Fluctuations in pain ratings vs number of cigarettes smoked
Fluctuations in pain ratings will be examined to determine their association with number of cigarettes smoked between each assessment.
Measured 5 times per day with random EMA prompts for 10 days
Participants without chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session.
Participants without chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session.
Participants in this condition will be asked to abstain from smoking or using any other tobacco products for 24 hours prior to the fMRI session
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
March 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 20, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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