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Beta Blocker
Behavioral + Propranolol for Misophonia (Miso Prop Trial)
Phase < 1
Waitlist Available
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
Summary
This trial is testing whether propranolol can help people with misophonia, a condition where certain sounds cause strong negative reactions. The medication aims to weaken the bad memories associated with these sounds. By doing so, it might make these sounds less distressing for those affected. Propranolol has been used in various psychiatric treatments and has shown potential in reducing anxiety and improving cognitive functions.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in average Galvanic skin response based on deflections of a wave
Secondary study objectives
Change in Approach-Avoidance test
Change in Average Galvanic skin response based on deflections of a wave
Change in average heart rate
+1 moreTrial 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
Counterconditioning
2023
Completed Early Phase 1
~290
Propranolol Hydrochloride tablet
2023
Completed Early Phase 1
~150
Reminder
2023
Completed Early Phase 1
~311310
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Misophonia often target the associative learning and memory processes that underlie the condition. Propranolol, a beta-blocker, is being studied for its ability to interfere with the reconsolidation of reactivated misophonia memories.
By disrupting the emotional learning and memory processes that reinforce negative responses to specific sounds, propranolol may alleviate the aversive reactions associated with Misophonia. This approach is significant for patients as it offers a targeted method to modify the neural pathways responsible for their condition, potentially leading to more effective and lasting relief.
Chronic propranolol induces deficits in retention but not acquisition performance in the water maze in mice.
Chronic propranolol induces deficits in retention but not acquisition performance in the water maze in mice.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
909 Previous Clinical Trials
542,019 Total Patients Enrolled
Daniela Schiller, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Laili Soleimani, MD, MscPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
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.