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Recruiting EARLY_Phase 1 NCT07271485

NCT07271485 Propranolol for Misophonia

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Clinical Trial Summary
NCT ID NCT07271485
Status Recruiting
Phase EARLY_Phase 1
Sponsor Bloom Mental Health, LLC
Condition Misophonia
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2025-12-19
Primary Completion 2026-12-19

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
propranololPlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 20 participants in total. It began in 2025-12-19 with a primary completion date of 2026-12-19.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The primary goal of this study is to investigate whether a one-time dose of 20 mg oral propranolol can temporarily reduce the adverse emotional and physical symptoms triggered by misophonia. The secondary goals of this study are: 1. Determine potential predictors of response to propranolol treatment, including demographic factors, baseline symptom severity, psychometric instrument item responses, and physiological characteristics. 2. Evaluate the safety and tolerability of propranolol in individuals with misophonia.

Eligibility Criteria

Inclusion Criteria: * Age 18-65. * Able to complete study visit(s) in Littleton, CO. * Able to give informed consent. * Participant reports clinically significant misophonia symptoms, as determined by answers on the standardized "Misophonia Trigger Screening Questions for Participants" form (described separately in the protocol). Specifically, participants must demonstrate relevant misophonia trigger responses that meet pre-specified minimum severity criteria detailed on this form. * A-MISO-S rating scale severity criterion: Participants must score at least a moderate ("2") or higher on question 2 and question 3 of the Amsterdam Misophonia Scale (A-MISO-S) at screening, since this indicates clinically meaningful misophonia severity for study eligibility. * Able to communicate misophonic distress in writing and reasonably participate in our outpatient clinical setting, meaning able to tolerate being in this outpatient clinical setting, follow the clinic rules for all patients and guests, and respond in an understandable fashion to questions administered to them. * Must agree to follow study clinician advice and seek additional care outside of this clinic if advised (e.g., if advised to seek help from emergency services for a potentially serious adverse reaction). * English fluency Exclusion Criteria: * Current use of scheduled propranolol for any condition. * Any of the known contraindications for taking propranolol: * cardiogenic shock * sinus bradycardia (\<50 bpm) * greater than first degree heart block * BP below 90/60 * asthma / bronchial asthma that requires treatment or medication, and/or has caused clinical concerns within the last 5 years * Other heart conditions that require ongoing medical treatment * Participants with any of the following relative contraindications for taking propranolol: * participants who have active anorexia, purging, or who are underweight (\<18.5 BMI) * Active drug or alcohol use within the last 48 hours prior to study participation, or active drug withdrawals * A history of untreated diabetes or other endocrine disorders that could be harmed by exposure to propranolol * history of cardiovascular disease or stroke, or symptomatic blood disorders such as anemia * history of any other severe physical or neurological conditions that may affect their ability to participate in the study * Participants with liver or kidney disease that would be affect or be affected by the study drug * Participants may, depending on the circumstances as decided by the study clinician, be excluded for any of the following conditions that may have adverse reactions to propranolol, including: Raynaud disease or other peripheral vascular disease, Pheochromocytoma, Psoriasis, Thyroid disease (untreated, and affected by propranolol), Unexplained dizziness, Oxygen level below 91%, Respirations below 12 or above 20 * Participants taking any other medications that could interfere with the effects of propranolol, as determined by the study clinician (e.g. other beta blockers, alpha blockers,prazosin, clonidine, guanfacine, diuretics, calcium channel blockers, acute us of anti-anxiety medications; other medications that interfere with the adrenergic system; or medications that have a significant effect on propranolol's pharmacology that would normally affect dosing in clinical practice * Allergy or sensitivity to propranolol, placebo ingredients, and/or capsule ingredients. * Pregnant or nursing. * Any of the following in 30 days prior to enrollment: active psychosis, suicidal/ self-harming / homicidal thoughts, bipolar mania, panic attacks, traumatic dissociation, Post-Traumatic Stress Disorder (PTSD) flashbacks, or psychiatric hospitalization. * Participant self-reports or clinical interview identifies any misophonia-triggered reactions within the past year that posed a significant risk to health or safety, including suicidal or homicidal ideation, or uncontrolled physical behaviors (e.g., self-injury, aggression toward others, throwing objects, screaming, or fleeing uncontrollably). This criterion is assessed via direct structured questioning during participant screening interviews and review of participant self-reports on standardized screening questionnaires. * Misophonia trigger symptoms are determined by a medical provider to be better explained by a condition other than Misophonia, such as hyperacusis or phonophobia. * Inability to hear routine sounds and communication (ie severe hearing impairment), only if it interferes with ability to hear the misophonia triggers on the video. * Participants who are triggered by the sound of water running or a car alarm (our control videos)

Contact & Investigator

Central Contact

Bloom Mental Health Clinic

✉ office@bloommh.com

📞 303-801-1776

Frequently Asked Questions

Who can join the NCT07271485 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Misophonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07271485 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT07271485 currently recruiting?

Yes, NCT07271485 is actively recruiting participants. Contact the research team at office@bloommh.com for enrollment information.

Where is the NCT07271485 trial being conducted?

This trial is being conducted at Littleton, United States.

Who is sponsoring the NCT07271485 clinical trial?

NCT07271485 is sponsored by Bloom Mental Health, LLC. The trial plans to enroll 20 participants.

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