NCT06983678 · Duke University
Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
(PRISM02)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Smoking as usual fMRI session
Participants in this condition will continue smoking as usual prior to the fMRI session
BEHAVIORAL
Abstinent 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
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- History of chronic non-cancer low back pain with duration ≥ 6 months OR no history of chronic pain;
- smoking of at least 10 cig/day for \> 2 years;
- have an iPhone or Android smartphone capable of running the EMA software
Exclusion criteria
- 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
- 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)
Where
- Durham, North Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations