Behavioral and Pharmacological Reconsolidation Interference in Misophonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Misophonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study team will measure reactivity to misophonia-related cues following either a pharmacological manipulation via a 40 mg propranolol tablet or behavioral manipulation via counterconditioning.

The study team predicts that participants with misophonia who experience a reminder (reactive a misophonia memory) and receive the pharmacological or behavioral manipulation, will show reduced reactivity to misophonia cues.

Other groups that undergo one of these components alone (reminder only, drug only, counterconditioning only) will continue to show heightened reactivity to misophonia cues.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

This study is multi-arm and single-site randomized study that is placebo-controlled and single- and double-blinded depending on the condition assignment. Some groups will experience reminders, or short exposures to misophonia-related cues. Some groups will take the study intervention, propranolol hydrochloride (or matching placebo) oral tablets, and some will undergo counterconditioning, by presenting the misophonia cues with monetary rewards (in a continuous reinforcement schedule with fixed monetary amounts).

Study Groups

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Memory Reminder followed by Propranolol Hydrochloride

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 Type EXPERIMENTAL

Propranolol Hydrochloride tablet

Intervention Type DRUG

Single dose of 40 mg propranolol tablet

Reminder

Intervention Type BEHAVIORAL

Reactivation of misophonia trigger memory

Memory reminder followed by Placebo

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.

Group Type PLACEBO_COMPARATOR

Reminder

Intervention Type BEHAVIORAL

Reactivation of misophonia trigger memory

Placebo

Intervention Type DRUG

Matching placebo tablet

No memory reminder followed by Propranolol Hydrochloride

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 Type EXPERIMENTAL

Propranolol Hydrochloride tablet

Intervention Type DRUG

Single dose of 40 mg propranolol tablet

Memory reminder followed by counterconditioning

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 Type EXPERIMENTAL

Reminder

Intervention Type BEHAVIORAL

Reactivation of misophonia trigger memory

Counterconditioning

Intervention Type BEHAVIORAL

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

No memory reminder followed by counterconditioning

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 Type EXPERIMENTAL

Counterconditioning

Intervention Type BEHAVIORAL

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

Interventions

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Propranolol Hydrochloride tablet

Single dose of 40 mg propranolol tablet

Intervention Type DRUG

Reminder

Reactivation of misophonia trigger memory

Intervention Type BEHAVIORAL

Counterconditioning

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

Intervention Type BEHAVIORAL

Placebo

Matching placebo tablet

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No