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Reducing Reconsolidation of Trauma Memories With Propranolol

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Propranolol
Short acting + long acting propranolol + memory reactivation
Sponsored by
Douglas Mental Health University Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Douglas Mental Health University InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Propranolol + Memory Reactivation

Placebo + Memory reactivation

Placebo + No Memory Reactivation

Propranolol + No Memory Reactivation

Open-label Propranolol + Memory Reactivation

Arm Description

This arm involves recalling the traumatic event after administration of propranolol

This arm involves recalling the traumatic event after administration of a placebo

This arm involves administration of a placebo without recalling the traumatic event

This arm involves administration of propranolol without recalling the traumatic event

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.

Outcomes

Primary Outcome Measures

Electromyogram
Heart rate
Skin conductance

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2011
Last Updated
June 23, 2014
Sponsor
Douglas Mental Health University Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01349439
Brief Title
Reducing Reconsolidation of Trauma Memories With Propranolol
Official Title
Reduction of the Reconsolidation of the Trauma Memory With Propranolol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propranolol + Memory Reactivation
Arm Type
Experimental
Arm Description
This arm involves recalling the traumatic event after administration of propranolol
Arm Title
Placebo + Memory reactivation
Arm Type
Experimental
Arm Description
This arm involves recalling the traumatic event after administration of a placebo
Arm Title
Placebo + No Memory Reactivation
Arm Type
Experimental
Arm Description
This arm involves administration of a placebo without recalling the traumatic event
Arm Title
Propranolol + No Memory Reactivation
Arm Type
Experimental
Arm Description
This arm involves administration of propranolol without recalling the traumatic event
Arm Title
Open-label Propranolol + Memory Reactivation
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
1mg per Kg (participant weight)
Intervention Type
Drug
Intervention Name(s)
Short acting + long acting propranolol + memory reactivation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electromyogram
Time Frame
Two weeks post-treatment
Title
Heart rate
Time Frame
Two weeks post-treatment
Title
Skin conductance
Time Frame
Two weeks post-treatment
Secondary Outcome Measure Information:
Title
PTSD symptom levels
Description
PTSD symptom levels will be assessed 2 to 26 weeks after randomization
Time Frame
2 to 26 weeks
Title
Quality of life
Description
Quality of life assessments will be conducted 2 to 26 weeks following randomization
Time Frame
2 to 26 weeks
Title
Memory Experience
Description
The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization
Time Frame
2 to 26 weeks
Title
Psychophysiological assessments
Description
Psychophysiological assessments will be repeated 26 weeks following randomization
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain R Brunet, Ph.D.
Phone
514-761-6131
Ext
4348
Email
alain.brunet@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Brunet, Ph.D.
Organizational Affiliation
Douglas Institute Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Douglas Mental Health University Institute
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Ashbaugh, Ph.D.
Phone
514-761-6131
Ext
4341
Email
andrea.ashbaugh@douglas.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Alain Brunet, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
17588604
Citation
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.
Results Reference
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Reducing Reconsolidation of Trauma Memories With Propranolol

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