Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke… (NCT06983678) | Clinical Trial Compass
RecruitingNot Applicable
Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain
United States132 participantsStarted 2025-11-04
Plain-language 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. 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.
Who can participate
Age range21 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
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
What they're measuring
1
Pain intensity ratings to high heat vs neutral temperatures
Timeframe: Measured at each fMRI session (up to 1.5 hours)
2
Activation of the inferior frontal gyrus (IFG)
Timeframe: Measured at each fMRI session (up to 1.5 hours)
3
Resting state functional connectivity with the IFG
Timeframe: Measured at each fMRI session (up to 1.5 hours)
4
Time to lapse
Timeframe: Measured daily during the 1-week abstinence test
5
Daily pain ratings
Timeframe: Measured with daily EMA prompts for 10 days
6
Daily withdrawal symptoms
Timeframe: Measured with daily EMA prompts for 10 days
7
Fluctuations in pain ratings vs smoking urge
Timeframe: Measured 5 times per day with random EMA prompts for 10 days
8
Fluctuations in pain ratings vs number of cigarettes smoked
Timeframe: Measured 5 times per day with random EMA prompts for 10 days