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Comparing Standard vs. Modified Reconsolidation Blockade for the Treatment of Psychological Trauma

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ClinicalTrials.gov Identifier: NCT04982211
Recruitment Status : Not yet recruiting
First Posted : July 29, 2021
Last Update Posted : July 29, 2021
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alain Brunet, Ph.D., Douglas Mental Health University Institute

Brief Summary:
The investigators propose to examine a mismatch-based method of reconsolidation blockade for the treatment of psychological trauma in military personnel and Federal police officers. The standard reconsolidation blockade treatment (aka Reconsolidation Therapy) involves reactivating the trauma memory while under the influence of propranolol. The mismatch method of Reconsolidation Therapy will involve varying the contexts in which the weekly trauma memory retrieval will occur. This study will involve 10 visits (eligibility assessment, treatments, and follow-up visits) over a 6-month period for each participant. Treatments will be conducted once a week for a six-week period where the participant will take a dose of propranolol (or a placebo pill) 60 minutes prior to memory reactivation. The investigators hypothesize that reconsolidation blockade treatment will be as effective in treating PTSD among military personnel and Federal police officers, with the mismatch condition showing greater symptom improvement.

Condition or disease Intervention/treatment Phase
Trauma and Stressor Related Disorders Post Traumatic Stress Disorder Acute Stress Disorder Adjustment Disorders Drug: Propranolol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 2 x 2 factorial randomized controlled trial. Factor 1 is the trauma reactivation method (standard vs. mismatch trauma reactivation) and factor 2 is the study medication (propranolol vs. placebo). The design will be stratified by profession (military vs. police) and sex. After an eligibility assessment at baseline, participants meeting inclusion criteria will be randomly allocated to one of four groups with a 66.6% probability of getting enrolled in one of the two propranolol treatment groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In this study, the investigators, therapists, outcomes assessors, and research participants will be blind to study medication allocation.
Primary Purpose: Treatment
Official Title: Comparing Standard vs. Modified Reconsolidation Blockade for the Treatment of Psychological Trauma: A Randomized Controlled Trial
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propranolol and standard trauma memory reactivation group
Oral propranolol will be administered 60 minutes prior to writing (Treatment 1) or reading aloud a trauma narrative.
Drug: Propranolol
Oral propranolol hydrochloride capsules, dosed per participant weight
Other Name: Teva propranolol

Placebo Comparator: Placebo and standard trauma memory reactivation group
Oral placebo will be administered 60 minutes prior to writing (Treatment 1) or reading aloud a trauma narrative.
Drug: Placebo
Oral placebo capsules, dosed per participant weight
Other Name: Placebo capsules

Active Comparator: Propranolol and mismatch trauma memory reactivation group
Oral propranolol will be administered 60 minutes prior to a memory reactivation procedure involving variations in the contexts where the trauma memory reactivations occur.
Drug: Propranolol
Oral propranolol hydrochloride capsules, dosed per participant weight
Other Name: Teva propranolol

Placebo Comparator: Placebo and mismatch trauma memory reactivation group
Oral placebo will be administered 60 minutes prior to a memory reactivation procedure involving variations in the contexts where the trauma memory reactivations occur.
Drug: Placebo
Oral placebo capsules, dosed per participant weight
Other Name: Placebo capsules




Primary Outcome Measures :
  1. Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5) scores [ Time Frame: Questionnaire administered at weeks 0 and 7 ]
    Change from baseline (week 0) to week 7 in PCL-5 scores


Secondary Outcome Measures :
  1. Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5) scores [ Time Frame: Questionnaire administered at weeks 0, 1, 2, 3, 4, 5, 6, 13 and 26 ]
    Changes from baseline in PCL-5 scores during treatment and at weeks 13 and 26

  2. Beck Depression Inventory (BDI) scores [ Time Frame: Questionnaire administered at weeks 0, 1, 2, 3, 4 , 5, 6, 7, 13 and 26 ]
    Changes from baseline in BDI scores during treatment and at week 26

  3. Clinical Global Impression-Improvement (CGI-I) scores [ Time Frame: Questionnaire administered at weeks 0, 7 and 26 ]
    Absolute CGI-I scores

  4. Mini Psychiatric Interview, version 7 (MINI-7) [ Time Frame: Questionnaire administered at weeks 0, 7 and 26 ]
    Proportion of participants who no longer meet PTSD diagnostic criteria at Weeks 7 and 26.

  5. Social Functioning Questionnaire (QFS) [ Time Frame: Questionnaire administered at weeks 0, 7, and 26 ]
    Changes from baseline in QFS scores

  6. World Health Organization - Quality of Life BREF [ Time Frame: Questionnaire administered at weeks 0, 7, and 26 ]
    Changes from baseline in World Health Organization - Quality of Life BREF scores

  7. Dissociative Experiences Scale (DES-T) [ Time Frame: Questionnaire administered at week 0. ]
    Changes from baseline in DES-T scores

  8. International Trauma Questionnaire (ITQ) [ Time Frame: Questionnaire administered at baseline and weeks 0, 7, and 26 ]
    Changes from baseline in ITQ scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(i) Male or female 18-65 years old;

(ii) Individuals who are either:

  • Employed full-time as part of the Canadian or US military forces or the RCMP;
  • On leave of absence from Canadian or US military forces, or the RCMP;
  • Veterans of the Canadian or US military forces or the RCMP;

(iii) Evidence of a personally signed and dated informed consent form;

(iv) Individuals suffering from occupationally related PTSD, as defined by the DSM-5, for 6 consecutive months or more.

(v) Females of childbearing potential willing to use contraception for the duration of the treatment period of the study.

Exclusion Criteria:

(i) Basal systolic blood pressure < 100 mm Hg;

(ii) Basal heart rate < 50 BPM;

(iii) Medical conditions contraindicating the administration of propranolol or beta blockers

(iv) A known hypersensitivity to propranolol or any of the study product or placebo ingredients;

(v) Clinically significant lactose intolerance;

(vi) Use of medication that involves unwanted interactions with propranolol including but not limited to other beta-blockers, anti-arrhythmic medications, and calcium channel blockers;

(vii) Current use of propranolol;

(viii) Pregnant or breast-feeding women;

(ix) Individuals with borderline personality, bipolar disorder, psychosis;

(x) Current DSM-5 substance dependence;

(xi) Active suicidal ideations, as demonstrated by a response of 2 or 3 on item 7 of the Beck Depression Inventory - Short Form;

(xii) A score below 'moderately ill' on the severity scale of the Clinical Global Impression scale;

(xiii) Participating in active litigation related to the traumatic event (Veterans Affairs Canada claims are permitted, excluding judicial claims);

(xiv) Strong dissociative tendencies, as evidenced by the Dissociative Experience Scale (8-item version, DES-T);

(xv) Suspected or confirmed traumatic brain injury during the last 24 months;

(xvi) Understanding neither English nor French;

(xvii) Participants who receive exposure-based cognitive-behavioral therapy during the treatment phase of the study;

(xviii) Presence of any medical condition that in the opinion of the investigator may compromise patient safety or study objectives.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982211


Contacts
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Contact: Alain Brunet, Ph.D. 514-761-6131 ext 4348 alain.brunet@mcgill.ca
Contact: Daniel Saumier, Ph.D. 514-761-6131 ext 4349 saumierd@gmail.com

Locations
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Canada, Quebec
Douglas Mental Health University Institute
Montréal, Quebec, Canada, H4H1R3
Sponsors and Collaborators
Douglas Mental Health University Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Alain Brunet, Ph.D. Douglas Mental Health University Institute
Publications:
Ecker B. Memory reconsolidation understood and misunderstood. International Journal of Neuropsychotherapy. 2015; 3(1): 2-46.
Fliess JL. The Design and Analysis of Clinical Experiments. New York: John Wiley,1986.
Desmeules J. Interations médicamenteuses et cytochromes P450. Pharma-Flash, 2002. 29(4): 13-16.
Benjamini, Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. Journal of the Royal Statistical Society.1995; Series B (Methodological): 289-300.

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Responsible Party: Alain Brunet, Ph.D., Primary Investigator and Full Professor, Department of Psychiatry, McGill University., Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT04982211    
Other Study ID Numbers: PRPL-008
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alain Brunet, Ph.D., Douglas Mental Health University Institute:
Memory Reconsolidation
Propranolol
Military personnel
Veterans
Mismatch
Efficacy
Additional relevant MeSH terms:
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Disease
Wounds and Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Psychological Trauma
Adjustment Disorders
Stress Disorders, Traumatic, Acute
Trauma and Stressor Related Disorders
Pathologic Processes
Mental Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents