Reducing Reconsolidation of Trauma Memories With Propranolol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Douglas Mental Health University Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT01349439
First received: March 31, 2011
Last updated: May 5, 2011
Last verified: March 2011

March 31, 2011
May 5, 2011
March 2011
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01349439 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • Drug: Propranolol
    1mg per Kg (participant weight)
  • 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.
  • Experimental: Propranolol + Memory Reactivation
    This arm involves recalling the traumatic event after administration of propranolol
    Intervention: Drug: Propranolol
  • Experimental: Placebo + Memory reactivation
    This arm involves recalling the traumatic event after administration of a placebo
    Intervention: Drug: Propranolol
  • Experimental: Placebo + No Memory Reactivation
    This arm involves administration of a placebo without recalling the traumatic event
    Intervention: Drug: Propranolol
  • Experimental: Propranolol + No Memory Reactivation
    This arm involves administration of propranolol without recalling the traumatic event
    Intervention: Drug: Propranolol
  • 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.
    Intervention: Drug: Short acting + long acting propranolol + memory reactivation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
Not Provided
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Alain R Brunet, Ph.D. 514-761-6131 ext 4348 alain.brunet@mcgill.ca
Canada
 
NCT01349439
08-44
No
Alain Brunet, Douglas Mental Health University Institute
Douglas Mental Health University Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Alain Brunet, Ph.D. Douglas Institute Research Centre
Douglas Mental Health University Institute
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP