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Behavioral + Propranolol for Misophonia (Miso Prop Trial)
Phase < 1
Recruiting
Led By Daniela Schiller, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 6 hours
Awards & highlights
Miso Prop Trial Summary
This trial aims to help treat misophonia using behavioural, computational and neural analyses to understand its underlying mechanisms and disrupt memory reconsolidation with propranolol.
Who is the study for?
This trial is for adults aged 18-55 with misophonia, which means they have strong negative reactions to certain sounds. Participants must speak English fluently and not be pregnant, breastfeeding, or have a pulse outside of the range 55-100 bpm. They should not take specific medications that interact with propranolol, have high or low blood pressure issues, cardiovascular illnesses, respiratory diseases like COPD, diabetes mellitus, CNS diseases or recent drug abuse.Check my eligibility
What is being tested?
The study tests if interfering with memory reconsolidation using propranolol can reduce aversive reactions in misophonia when reminded of triggering sounds. It compares this approach against placebo and counterconditioning techniques through behavioral and neural analyses.See study design
What are the potential side effects?
Propranolol may cause side effects such as dizziness, fatigue, trouble sleeping, stomach cramps and nausea. In some cases it might also affect heart rate and blood pressure or worsen breathing problems.
Miso Prop Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and after 6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 6 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in average Galvanic skin response based on deflections of a wave
Secondary outcome measures
Change in Approach-Avoidance test
Change in Average Galvanic skin response based on deflections of a wave
Change in average heart rate
+1 moreMiso Prop Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: No memory reminder followed by counterconditioningExperimental Treatment1 Intervention
This arm aims to have 30 participants with a behavioral manipulation. They will not receive a reminder to reactivate their memory of a misophonia trigger and then undergo counterconditioning.
Group II: No memory reminder followed by Propranolol HydrochlorideExperimental Treatment1 Intervention
This arm aims to have 30 participants with a pharmacological manipulation. They will not receive a reminder to reactivate their memory of a misophonia sound and only receive a propranolol hydrochloride tablet.
Group III: Memory reminder followed by counterconditioningExperimental Treatment2 Interventions
This arm aims to have 30 participants with a behavioral manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger and then will undergo counterconditioning.
Group IV: Memory Reminder followed by Propranolol HydrochlorideExperimental Treatment2 Interventions
This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a propranolol hydrochloride tablet.
Group V: Memory reminder followed by PlaceboPlacebo Group2 Interventions
This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a placebo tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reminder
2022
N/A
~311170
Counterconditioning
2018
N/A
~140
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,476 Total Patients Enrolled
Daniela Schiller, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
James Murrough, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
224 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, as the study involves risks to unborn children.My blood pressure is not between 100/60 and 150/100, or I need medication to manage it.I have diabetes.I am between 18 and 55 years old.I regularly take medication that affects the same body process as propranolol.I have a heart condition that needs medication.I do not have any conditions that make propranolol unsafe for me.I am not currently breastfeeding.I do not have a history of significant brain or neurological issues.I have a chronic lung condition like asthma or COPD.
Research Study Groups:
This trial has the following groups:- Group 1: No memory reminder followed by Propranolol Hydrochloride
- Group 2: Memory reminder followed by Placebo
- Group 3: Memory Reminder followed by Propranolol Hydrochloride
- Group 4: No memory reminder followed by counterconditioning
- Group 5: Memory reminder followed by counterconditioning
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 55 and over being accepted into the trial?
"This medical trial is seeking volunteers aged 18 and above, yet younger than 55."
Answered by AI
Who can participate in this medical experiment?
"Prerequisites for this medical trial include having misophonia and being aged between 18 to 55. In total, approximately 150 participants are needed."
Answered by AI
Is the recruitment process still open for this investigation?
"A review of clinicaltrials.gov reveals that this particular medical trial, which launched on June 2nd 2023 and was last updated two weeks later, is not presently enrolling patients. Nonetheless, there are still other trials seeking participants."
Answered by AI
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