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Beta Blocker

Propranolol for PTSD

Phase 2

Waitlist Available

Led By Alain Brunet, Ph.D.

Research Sponsored by Douglas Mental Health University Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal

Be older than 18 years old

Must not have

Medical conditions that contraindicate the administration of propranolol

Any medication that can have an impact on cardiac rhythm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 to 26 weeks

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests whether propranolol can help to treat symptoms of PTSD by reducing physiological reactions to trauma reminders.

Who is the study for?

This trial is for adults who have been living with chronic PTSD for at least six months and score high on a trauma impact scale. Participants over 40 must have a normal heart reading from an ECG. They should not start new medications during the study or be taking drugs that affect heart rhythm, and cannot be breastfeeding, have bipolar disorder or psychosis, substance abuse issues, high dissociation levels, or certain medical conditions.

What is being tested?

The study tests if propranolol (a beta-blocker), given in short-acting and long-acting forms along with memory reactivation sessions, can reduce physical responses to trauma memories and ease PTSD symptoms compared to just propranolol without memory reactivation.

What are the potential side effects?

Propranolol may cause low blood pressure, slow heartbeat, fatigue, dizziness upon standing up too fast due to lowered blood pressure (orthostatic hypotension), sleep disturbances, and could potentially worsen symptoms of asthma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 or older and agree to a heart test that must show normal results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health issues that prevent me from taking propranolol.

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I am taking medication that affects my heart rhythm.

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I have low blood pressure.

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I am taking medication that could dangerously interact with propranolol.

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I have or had bipolar disorder or psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 to 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Memory Experience

PTSD symptom levels

Psychophysiological assessments

+1 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Propranolol + No Memory ReactivationExperimental Treatment1 Intervention

This arm involves administration of propranolol without recalling the traumatic event

Group II: Propranolol + Memory ReactivationExperimental Treatment1 Intervention

This arm involves recalling the traumatic event after administration of propranolol

Group III: Placebo + No Memory ReactivationExperimental Treatment1 Intervention

This arm involves administration of a placebo without recalling the traumatic event

Group IV: Placebo + Memory reactivationExperimental Treatment1 Intervention

This arm involves recalling the traumatic event after administration of a placebo

Group V: Open-label Propranolol + Memory ReactivationExperimental Treatment1 Intervention

All participants terminating the double-blind phase of the study will receive open-label reconsolidation blockade treatment with propranolol combined with recall of the traumatic event for six weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

FDA approved

0 / 6Eligibility criteria met