Clinical trial NCT05928689: Behavioral and Pharmacological Reconsolidation Interference in Misophonia
Official title: Misophonia-Related Memory Modification Using Reconsolidation Mechanisms: Pharmacological and Behavioral Manipulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Misophonia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in average Galvanic skin response based on deflections of a wave
timeFrame: Baseline and after 6 hours
measure: Change in average heart rate
timeFrame: Baseline and after 6 hours
measure: Change in Approach-Avoidance test
timeFrame: Baseline and after 6 hours
Secondary outcomes:
measure: Change in Approach-Avoidance test
timeFrame: about 1 week later
measure: Change in Approach-Avoidance test
timeFrame: Baseline and 1 month later
measure: Change in decision making task
timeFrame: Baseline and after 6 hours
measure: Change in decision making task
timeFrame: Baseline and about 1 week
measure: Change in decision making task
timeFrame: Baseline and 1 month later
measure: Change in Average Galvanic skin response based on deflections of a wave
timeFrame: about 1 week later
measure: Change in Average Galvanic skin response based on deflections of a wave
timeFrame: about 1 month later
measure: Change in average heart rate
timeFrame: about 1 week later
measure: Change in average heart rate
timeFrame: about 1 month later
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniela Schiller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: James Murrough, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Laili Soleimani, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References: