Tobacco UsePRISM02NCT06983678
Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
A study testing Smoking as usual fMRI session and Abstinent fMRI session in people with Tobacco Use and Chronic Pain, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Tobacco Use, Chronic Pain
- What is being tested?
- Smoking as usual fMRI session and Abstinent fMRI session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of chronic non-cancer low back pain with duration ≥ 6 months OR no history of chronic pain;
- age 21-65;
- smoking of at least 10 cig/day for > 2 years;
- have an iPhone or Android smartphone capable of running the EMA software
Who cannot join
- pain complaint specifically due to cancer, rheumatoid arthritis, or complex regional pain syndrome;
- actively taking steps to quit smoking;
- inability to attend all required experimental sessions;
- significant health problems, such as chronic hypertension, emphysema, seizure disorder, history of significant heart problems;
- conditions that would make MRI scanning unsafe (e.g., metal implants, claustrophobia)
- use of opioids within the past 90 days
Show all 16Show fewer
- past year alcohol or substance use disorder
- positive urine test for illegal drugs (other than marijuana);
- daily use of alcohol or marijuana;
- lifetime history of psychotic disorder, or current unstable psychiatric disorder;
- regular use of non-cigarette tobacco products or electronic cigarettes;
- major surgery within the past 6 months or planned surgery within the timeframe of the study;
- breath alcohol level > 0.0 (participants failing for BAL will be allowed to rescreen once);
- recently quit smoking for > 3 days;
- pregnancy or planning to become pregnant;
- any factors that at the discretion of the investigators would adversely affect the participant or integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke North Pavilion
Durham, North Carolina, 27705
Clinical Research Coordinator, 984-209-9816, sweitzerlab@duke.edu
About this study
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.
Read the detailed description
Eligible participants will complete an initial in-person screening session in which eligibility is confirmed and baseline pain and smoking measures are collected, followed by a sensory testing and training session, in which participants are introduced to the mock MRI scanner and familiarized with the thermal pain stimulation and psychophysiological rating procedures. Participants will then complete two fMRI sessions using a within-subjects, crossover design, with one scan following 24-hrs abstinence from smoking, and the other following smoking as usual. Both fMRI sessions will be identical other than the smoking instructions prior to the scan. During each scan, participants will complete experience and provide ratings to painful heat stimuli. Before and after scanning, participants will complete measures of craving, withdrawal, and current pain level. After completion of the scanning sessions, participants will return to the lab for a baseline visit prior to beginning the abstinence test. During that session, they will have software installed on their smartphone for ecological momentary assessment (EMA), and they will be trained in the procedures for biochemical verification of abstinence. They will then complete 3 days of baseline EMA, during which participants are prompted at 5 random times throughout the day, and once in the evening, to answer questions about their pain, smoking urge, and recent smoking. They will then continue EMA while attempting to abstain from smoking during the 1-week abstinence test. During the abstinence test, each day of abstinence is reinforced with money using a descending schedule. Participants will provide breath samples over video during this week using equipment provided by the lab in order to verify abstinence from smoking. At the conclusion of the study, participants will return to the lab for a final visit to return all equipment.
- Conditions
- Tobacco Use, Chronic Pain
- Being tested
- Smoking as usual fMRI session, Abstinent fMRI session
- Medical subject headings
- Tobacco Use, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking as usual fMRI sessionBehavioural
Participants in this condition will continue smoking as usual prior to the fMRI session
Abstinent fMRI sessionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI | Experimental | Participants with chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session. Receives: Behavioral: Smoking as usual fMRI session; Behavioral: Abstinent fMRI session |
| Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI | Experimental | Participants with chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session. Receives: Behavioral: Smoking as usual fMRI session; Behavioral: Abstinent fMRI session |
| Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI | Experimental | Participants without chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session. Receives: Behavioral: Smoking as usual fMRI session; Behavioral: Abstinent fMRI session |
| Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI | Experimental | Participants without chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session. Receives: Behavioral: Smoking as usual fMRI session; Behavioral: Abstinent fMRI session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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
Measured: 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: 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: 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: Measured 5 times per day with random EMA prompts for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start4 Nov 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Maggie Sweitzer, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983678
- Sponsor's protocol ID
- Pro00117759
- Other IDs
- 1R01DA060859-01A1
- Acronym
- PRISM02
- Status last verified
- Nov 2025
- First submitted
- 14 May 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
- ClinicalTrials.gov ID
- NCT06983678
- Acronym / sponsor ID
- PRISM02 / Pro00117759
- Conditions
- Tobacco Use, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants will complete an initial in-person screening session in which eligibility is confirmed and baseline pain and smoking measures are collected, followed by a sensory testing and training session, in which participants are introduced to the mock MRI scanner and familiarized with the thermal pain stimulation and psychophysiological rating procedures. Participants will then complete two fMRI sessions using a within-subjects, crossover design, with one scan following 24-hrs abstinence from smoking, and the other following smoking as usual. Both fMRI sessions will be identical other than the smoking instructions prior to the scan. During each scan, participants will complete experience and provide ratings to painful heat stimuli. Before and after scanning, participants will complete measures of craving, withdrawal, and current pain level. After completion of the scanning sessions, participants will return to the lab for a baseline visit prior to beginning the abstinence test. During that session, they will have software installed on their smartphone for ecological momentary assessment (EMA), and they will be trained in the procedures for biochemical verification of abstinence. They will then complete 3 days of baseline EMA, during which participants are prompted at 5 random times throughout the day, and once in the evening, to answer questions about their pain, smoking urge, and recent smoking. They will then continue EMA while attempting to abstain from smoking during the 1-week abstinence test. During the abstinence test, each day of abstinence is reinforced with money using a descending schedule. Participants will provide breath samples over video during this week using equipment provided by the lab in order to verify abstinence from smoking. At the conclusion of the study, participants will return to the lab for a final visit to return all equipment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI | Experimental | Behavioral: Smoking as usual fMRI session, Behavioral: Abstinent fMRI sessionParticipants with chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session. |
| Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI | Experimental | Behavioral: Smoking as usual fMRI session, Behavioral: Abstinent fMRI sessionParticipants with chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session. |
| Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI | Experimental | Behavioral: Smoking as usual fMRI session, Behavioral: Abstinent fMRI sessionParticipants without chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session. |
| Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI | Experimental | Behavioral: Smoking as usual fMRI session, Behavioral: Abstinent fMRI sessionParticipants without chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of chronic non-cancer low back pain with duration ≥ 6 months OR no history of chronic pain;
- age 21-65;
- smoking of at least 10 cig/day for > 2 years;
- have an iPhone or Android smartphone capable of running the EMA software
Key exclusion criteria (16 listed)
- pain complaint specifically due to cancer, rheumatoid arthritis, or complex regional pain syndrome;
- actively taking steps to quit smoking;
- inability to attend all required experimental sessions;
- significant health problems, such as chronic hypertension, emphysema, seizure disorder, history of significant heart problems;
- conditions that would make MRI scanning unsafe (e.g., metal implants, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking as usual fMRI sessionParticipants in this condition will continue smoking as usual prior to the fMRI session | Behavioural | Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI, Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI, Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI, Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI |
| Abstinent fMRI sessionParticipants in this condition will be asked to abstain from smoking or using any other tobacco products for 24 hours prior to the fMRI session | Behavioural | Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI, Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI, Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI, Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI |
Primary outcome
Pain intensity ratings to high heat vs neutral temperatures
Time frame: Measured at each fMRI session (up to 1.5 hours)
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.
Activation of the inferior frontal gyrus (IFG)
Time frame: Measured at each fMRI session (up to 1.5 hours)
% signal change in response to the contrast of high heat vs rest will be extracted from right and left IFG
Resting state functional connectivity with the IFG
Time frame: Measured at each fMRI session (up to 1.5 hours)
Fisher-Z transformed correlation maps of connectivity with the IFG will be evaluated within a subcortical mask including the caudate and thalamus
Time to lapse
Time frame: Measured daily during the 1-week abstinence test
The number of days of continuous, biochemically verified abstinence prior to smoking
Daily pain ratings
Time frame: Measured with daily EMA prompts for 10 days
Mean pain ratings during the initial days of abstinence will be examined as a function of chronic pain status, assessed at baseline
Daily withdrawal symptoms
Time frame: Measured with daily EMA prompts for 10 days
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
Fluctuations in pain ratings vs smoking urge
Time frame: Measured 5 times per day with random EMA prompts for 10 days
Fluctuations in pain ratings will be examined to determine their association with level of smoking urge
Fluctuations in pain ratings vs number of cigarettes smoked
Time frame: Measured 5 times per day with random EMA prompts for 10 days
Fluctuations in pain ratings will be examined to determine their association with number of cigarettes smoked between each assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maggie Sweitzer, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking as usual fMRI session and Abstinent fMRI session in people with Tobacco Use and Chronic Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (919-907-9955, sweitzerlab@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity ratings to high heat vs neutral temperatures (time frame: Measured at each fMRI session (up to 1.5 hours)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.