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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
Subject must have no current or recent history of pathological pain
Subject must have abstained from alcohol and substance use for 48 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hour 2 of fmri scanning, immediately after each pain delivery trial.
Awards & highlights
WASABI 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.Check my eligibility
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.See study design
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.
WASABI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You should not have any ongoing or recent severe pain.
Select...
You haven't consumed alcohol or used any drugs for the past 48 hours.
WASABI Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
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.
WASABI 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
~3780
Find a Location
Who is running the clinical trial?
Trustees of Dartmouth CollegeLead Sponsor
23 Previous Clinical Trials
10,535 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
Media Library
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for volunteers as part of this experiment?
"Clinicaltrials.gov suggests that this trial is recruiting subjects; it was first published on March 19th 2021 and has had its details updated most recently on October 25th 2022."
Answered by AI
What is the current enrollment for this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is currently recruiting, with the posting originating on March 19th 2021 and last adjusted on October 25th 2022. The research necessitates 150 candidates to be recruited from 1 medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I was interested and still am.
PatientReceived 1 prior treatment
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