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Placebo for Pain Management (WASABI Trial)
N/A
Recruiting
Led By Tor D Wager, PhD
Research Sponsored by Trustees of Dartmouth College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 2 of fmri scanning, immediately after each pain delivery trial.
Summary
This trial will study how the brain processes pain signals when given a placebo cream, with the goal of understanding how placebos can affect pain perception.
Who is the study for?
This study is for volunteers over 18, with no history of pathological pain or chronic conditions, who can tolerate heat on their forearm. They must not be pregnant, have metal in their body, suffer from severe cardiovascular issues or neurological disorders, smoke heavily, use alcohol frequently, or have had recent psychoactive substance abuse.
What is being tested?
The trial tests the effects of a placebo cream on brain activity during painful heat exposure to different body sites using fMRI scans. It aims to see if the placebo alters how the brain processes and anticipates pain before and during thermal stimulation.
What are the potential side effects?
Since this trial involves a placebo cream (with no active medication), side effects are expected to be minimal. However, participants may experience discomfort from the heat pain applied during testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hour 2 of fmri scanning, immediately after each pain delivery trial.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hour 2 of fmri scanning, immediately after each pain delivery trial.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Contrast of pain intensity using the Bartoshuk Labeled Magnitude Scale (LMS) between body sites administered Placebo vs. Control Cream, both prior to and during pain delivery.
Contrasts of pain valence (i.e., unpleasantness) using the Bartoshuk Labeled Magnitude Scale (LMS) between body sites administered Placebo vs. Control Cream, both prior to and during pain delivery.
Secondary study objectives
Contrasts of activation of eight fMRI somatotopic signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
Contrasts of activation of fMRI aversiveness signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
Contrasts of activation of fMRI sensation signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
Other study objectives
Contrast of scalar activation of Neurologic Pain Signature between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo Cream firstExperimental Treatment2 Interventions
Each participant will undergo thermal pain tasks after being administered a "treatment" cream to one of eight body sites.
Group II: Control Cream firstExperimental Treatment2 Interventions
Each participant will undergo thermal pain tasks after being administered a "control" cream to one of eight body sites.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Cream
2014
Completed Phase 4
~3800
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Who is running the clinical trial?
Trustees of Dartmouth CollegeLead Sponsor
27 Previous Clinical Trials
11,121 Total Patients Enrolled
2 Trials studying Pain
180 Patients Enrolled for Pain
Tor D Wager, PhDPrincipal InvestigatorDartmouth College
5 Previous Clinical Trials
383 Total Patients Enrolled
2 Trials studying Pain
180 Patients Enrolled for Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not have any current or recent history of severe pain.You have metal in your body or have worked with metal fragments in the past (like as a machinist).You cannot handle heat pain applied to your forearm.You have certain hormone-related disorders like Cushing's disease.You smoke more than 5 cigarettes a day on a regular basis.You are unable to handle the scanning procedures due to reasons like feeling trapped or scared.You have had an allergic reaction to the exfoliating cream.You are currently experiencing pain.You have long-lasting pain conditions.You have chronic fatigue syndrome.You have a neurological disorder like Parkinson's and take medication that affects dopamine. You also have a cardiovascular condition and take medication like ACE inhibitors for heart health.You should not have any ongoing or recent severe pain.You haven't consumed alcohol or used any drugs for the past 48 hours.You are experiencing temporary and abnormal levels of pain.You have a history of using drugs or becoming dependent on them.You have a condition called dementia.You have movement disorders, except for familial tremor.You have inflammation in the blood vessels of your brain and spinal cord.You have an inflammatory or autoimmune disease.You were born with a brain condition like cerebral palsy.You have a history of seizures.You have had an injury to your head that caused you to lose consciousness.You have a history of stroke or mini-strokes (TIAs).You have frequent migraines, which means you get more than 5 headaches a month on average.You have a history of neurological disease or chronic nerve pain.You have previously been treated with certain medications like antipsychotics, isoniazid, or drugs that affect blood pressure control in the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Cream first
- Group 2: Control Cream first
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pain Patient Testimony for trial: Trial Name: NCT04653064 — N/A
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