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Posttraumatic Stress Disorder | Reducing Reconsolidation of Trauma Memories With Propranolol

Posttraumatic Stress Disorder research study

What is the primary objective of this study?

The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.

Who is eligible to participate?

Inclusion Criteria: - Suffer from chronic PTSD for at least 6 consecutive months; - Obtain a score of 33 or more on the Impact of Events Scale-Revised: - For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal; - Accept to not commence taking new medications on a regular basis during the study. Exclusion Criteria: - Hypotension; - Cardiac rhythm below 55 beats per minute; - Medical conditions that contraindicates the administration of propranolol; - Previous adverse reaction to, or non-compliance with, beta-blockers; - Current use of medication that may involve potentially dangerous interactions with propranolol; - Any medication that can have an impact on cardiac rhythm; - Women who are breast feeding; - Past or present bipolar disorder or psychosis, - Present substance abuse or dependence, suicidal ideation; - Participating in psychotherapy other than support psychotherapy; - An average score above 20 on the Dissociative Experience Scale.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Posttraumatic Stress Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Propranolol1mg per Kg (participant weight)

Drug:Short acting + long acting propranolol + memory reactivationAfter completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Propranolol + Memory ReactivationThis arm involves recalling the traumatic event after administration of propranolol

Placebo + Memory reactivationThis arm involves recalling the traumatic event after administration of a placebo

Placebo + No Memory ReactivationThis arm involves administration of a placebo without recalling the traumatic event

Propranolol + No Memory ReactivationThis arm involves administration of propranolol without recalling the traumatic event

Open-label Propranolol + Memory ReactivationAll 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.

Study Status

Unknown status

Start Date: March 2011

Completed Date:

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Electromyogram

Secondary Outcome: PTSD symptom levels

Study sponsors, principal investigator, and references

Principal Investigator: Alain Brunet, Ph.D.

Lead Sponsor: Douglas Mental Health University Institute

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01349439

Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. Epub 2007 Jun 22.

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