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Reconsolidation Blockade with 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

Male or female 18-65 years old

Be older than 18 years old

Must not have

Clinically significant lactose intolerance

Medical conditions contraindicating the administration of propranolol or beta blockers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up questionnaire administered at weeks 0, 1, 2, 3, 4 , 5, 6, 7, 13 and 26

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial will examine whether a new method of reconsolidation blockade, which involves varying the contexts in which the weekly trauma memory retrieval will occur, is effective in treating PTSD among military personnel and Federal police officers.

Who is the study for?

This trial is for military personnel, Federal police officers, or veterans aged 18-65 with occupationally related PTSD as per DSM-5 criteria. Participants must be able to consent and females should use contraception. Exclusions include medical conditions that conflict with propranolol use, certain medication interactions, pregnancy, substance dependence, ongoing litigation related to trauma, strong dissociative tendencies, language barriers (non-English/French speakers), low blood pressure/heart rate, active suicidal thoughts or recent traumatic brain injury.

What is being tested?

The study tests a modified reconsolidation therapy for psychological trauma using propranolol versus placebo. Over six weeks of treatment involving weekly sessions preceded by drug intake an hour before memory reactivation; the mismatch method varies contexts of retrieval. The hypothesis suggests this could improve PTSD symptoms more effectively than standard methods.

What are the potential side effects?

Propranolol may cause side effects like dizziness due to lowered blood pressure, fatigue, trouble sleeping and cold hands or feet. It can also affect heart rhythm and breathing in some individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have a severe reaction to lactose.

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I cannot take propranolol or beta blockers due to my medical condition.

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I am currently taking propranolol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ questionnaire administered at weeks 0, 1, 2, 3, 4 , 5, 6, 7, 13 and 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~questionnaire administered at weeks 0, 1, 2, 3, 4 , 5, 6, 7, 13 and 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaire administered at weeks 0, 1, 2, 3, 4 , 5, 6, 7, 13 and 26 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Beck Depression Inventory (BDI) scores

Clinical Global Impression-Improvement (CGI-I) scores

Dissociative Experiences Scale (DES-T)

+5 more

Awards & Highlights

All Individual Drugs Already Approved

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Propranolol and standard trauma memory reactivation groupExperimental Treatment1 Intervention

Oral propranolol will be administered 60 minutes prior to writing (Treatment 1) or reading aloud a trauma narrative.

Group II: Propranolol and mismatch trauma memory reactivation groupActive Control1 Intervention

Oral propranolol will be administered 60 minutes prior to a memory reactivation procedure involving variations in the contexts where the trauma memory reactivations occur.

Group III: Placebo and mismatch trauma memory reactivation groupPlacebo Group1 Intervention

Oral placebo will be administered 60 minutes prior to a memory reactivation procedure involving variations in the contexts where the trauma memory reactivations occur.

Group IV: Placebo and standard trauma memory reactivation groupPlacebo Group1 Intervention

Oral placebo will be administered 60 minutes prior to writing (Treatment 1) or reading aloud a trauma narrative.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

FDA approved

0 / 4Eligibility criteria met