Behavioral and Pharmacological Reconsolidation Interference in Misophonia

Early Phase 1CompletedNCT05928689

Icahn School of Medicine at Mount Sinai141 enrolled

Overview

One of the core processes presumably underlying misophonia - a condition characterized by decreased tolerance for specific sounds - is associative learning. Using behavioral, computational, and neural analyses of emotional learning and memory processes to understand the unknown behavioral and neural mechanisms underlying misophonia's associative learning and memory, the study team will evaluate whether interference with the reconsolidation of a reactivated misophonia memory with propranolol can alleviate aversive reaction to misophonia-related cues.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

141

Conditions

Misophonia

Interventions

Propranolol Hydrochloride tabletDRUG

Single dose of 40 mg propranolol tablet

ReminderBEHAVIORAL

Reactivation of misophonia trigger memory

CounterconditioningBEHAVIORAL

Counterconditioning will consist of presentation of misophonia cues paired with monetary rewards.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear. * Must be between the ages of 18 - 55. * Must be fluent in English since the study's instructions, surveys, and tasks will be in English Exclusion Criteria: * Disability or medical condition that prohibits completion of study. Participants must be able to complete all study procedures to ensure optimal conditions for data analysis. * CNS disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, history of head trauma (defined as loss of consciousness\>3 min), or history of seizures without a resolved etiology. CNS disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity. We wish to minimize confounding variables. * Recently used drugs of abuse. * Pregnancy. The risks associated with neither propranolol exposure during gestation have been studied extensively. We wish to safeguard the health of potential participants and their children. * Lactation. Propranolol is excreted in human breast-milk, and its impact on infant development has not been studied. We wish to safeguard the health of potential participants and their children. * Regular use of medication metabolized in the CYP2D6, 1A2, or 2C19 pathways. Drugs that are metabolized in the same pathway as propranolol may increase its efficacy or toxicity. We wish to safeguard the health of participants. * Blood pressure over 150/100 or under 100/60 (applicable for either systolic or diastolic measures) and any hypertension requiring medication. Propranolol is known to pose additional risk to individuals with a number of medical conditions. We wish to safeguard the health of our participants. * Pulse over 100 or under 55. * History of cardiovascular illness such as cardiac arrhythmia, coronary heart disease or any cardiac dysfunction that requires medication. * Active respiratory illness including bronchospastic pulmonary disease and chronic obstructive pulmonary disease * Diabetes mellitus. * Other medical conditions that make it unsafe to take propranolol (e. g. allergy to propranolol).

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Change in average Galvanic skin response based on deflections of a wave

Using galvanic skin response based on deflections of a wave, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. A greater deflection indicates greater sympathetic nervous system arousal.

Time frame: Baseline and after 6 hours

Change in average heart rate

Using heart rate measurement, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. Reduced heart rate will indicate manipulation efficacy

Time frame: Baseline and after 6 hours

Change in Approach-Avoidance test

Using an approach-avoidance test, the difference between the monetary amounts earned before and after the pharmacological or behavioral manipulation will be measured. The minimum monetary amount earned is $0 and the maximum monetary amount earned is $23. A higher monetary amount earned indicates greater approach towards an avoidant cue. The difference in monetary amounts across conditions will be compared.

Time frame: Baseline and after 6 hours

Secondary Outcomes

Change in Approach-Avoidance test

Time frame: about 1 week later

Change in Approach-Avoidance test

Data from ClinicalTrials.gov

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