Reducing Reconsolidation of Trauma Memories With Propranolol

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Douglas Mental Health University Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alain Brunet, Ph.D., Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT01349439
First received: March 31, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: Propranolol
Drug: Short acting + long acting propranolol + memory reactivation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reduction of the Reconsolidation of the Trauma Memory With Propranolol

Resource links provided by NLM:


Further study details as provided by Douglas Mental Health University Institute:

Primary Outcome Measures:
  • Electromyogram [ Time Frame: Two weeks post-treatment ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Two weeks post-treatment ] [ Designated as safety issue: No ]
  • Skin conductance [ Time Frame: Two weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptom levels [ Time Frame: 2 to 26 weeks ] [ Designated as safety issue: No ]
    PTSD symptom levels will be assessed 2 to 26 weeks after randomization

  • Quality of life [ Time Frame: 2 to 26 weeks ] [ Designated as safety issue: No ]
    Quality of life assessments will be conducted 2 to 26 weeks following randomization

  • Memory Experience [ Time Frame: 2 to 26 weeks ] [ Designated as safety issue: No ]
    The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization

  • Psychophysiological assessments [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Psychophysiological assessments will be repeated 26 weeks following randomization


Estimated Enrollment: 76
Study Start Date: March 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349439

Contacts
Contact: Alain R Brunet, Ph.D. 514-761-6131 ext 4348 alain.brunet@mcgill.ca

Locations
Canada, Quebec
Douglas Mental Health University Institute Recruiting
Verdun, Quebec, Canada, H4H 1R3
Contact: Andrea Ashbaugh, Ph.D.    514-761-6131 ext 4341    andrea.ashbaugh@douglas.mcgill.ca   
Principal Investigator: Alain Brunet, Ph.D.         
Sponsors and Collaborators
Douglas Mental Health University Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Alain Brunet, Ph.D. Douglas Institute Research Centre
  More Information

Additional Information:
Publications:
Responsible Party: Alain Brunet, Ph.D., Dr., Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT01349439     History of Changes
Other Study ID Numbers: 08-44
Study First Received: March 31, 2011
Last Updated: June 23, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014