Reducing Reconsolidation of Trauma Memories With Propranolol

Reduction of the Reconsolidation of the Trauma Memory With Propranolol

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.

Study Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Drug: Propranolol; Drug: Short acting + long acting propranolol + memory reactivation

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alain R Brunet, Ph.D.; Phone Number: 4348 514-761-6131; Email: alain.brunet@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Verdun, Quebec, Canada, H4H 1R3
      • Recruiting
      • Douglas Mental Health University Institute
      • Contact: Andrea Ashbaugh, Ph.D.; Phone Number: 4341 514-761-6131; Email: andrea.ashbaugh@douglas.mcgill.ca
      • Principal Investigator: Alain Brunet, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propranolol + Memory Reactivation; This arm involves recalling the traumatic event after administration of propranolol	Drug: Propranolol; 1mg per Kg (participant weight)
Experimental: Placebo + Memory reactivation; This arm involves recalling the traumatic event after administration of a placebo	Drug: Propranolol; 1mg per Kg (participant weight)
Experimental: Placebo + No Memory Reactivation; This arm involves administration of a placebo without recalling the traumatic event	Drug: Propranolol; 1mg per Kg (participant weight)
Experimental: Propranolol + No Memory Reactivation; This arm involves administration of propranolol without recalling the traumatic event	Drug: Propranolol; 1mg per Kg (participant weight)
Other: Open-label Propranolol + Memory Reactivation; 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.	Drug: Short acting + long acting propranolol + memory reactivation; After 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Electromyogram	Two weeks post-treatment
Heart rate	Two weeks post-treatment
Skin conductance	Two weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptom levels	PTSD symptom levels will be assessed 2 to 26 weeks after randomization	2 to 26 weeks
Quality of life	Quality of life assessments will be conducted 2 to 26 weeks following randomization	2 to 26 weeks
Memory Experience	The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization	2 to 26 weeks
Psychophysiological assessments	Psychophysiological assessments will be repeated 26 weeks following randomization	26 weeks

Collaborators and Investigators

• Sponsor: Douglas Mental Health University Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Alain Brunet, Ph.D., Douglas Institute Research Centre

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): January 1, 2015
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: March 31, 2011
• First Submitted That Met QC Criteria: May 5, 2011
• First Posted (Estimate): May 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 08-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No