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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03152175
Other study ID # PRPL-007
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 30, 2017
Est. completion date March 2023

Study information

Verified date June 2021
Source Douglas Mental Health University Institute
Contact Alain Brunet, PhD.
Phone 514-761-6131
Email alain.brunet@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Police officers, correctional service officers, and 911-operators are at increased risk for suffering from trauma-related disorders due to their direct and indirect exposure to life-threatening events, such as shootings, violent assaults, or car accidents, among others. Typical treatments for post-traumatic stress disorders include psychotherapy and pharmacological therapies (i.e., antidepressants). Although these interventions are effective for many sufferers, they all have limitations. Thus, the investigators propose to explore the usefulness of a new therapeutic technique, reconsolidation blockade, which involves reactivating the trauma memory while under the influence of propranolol. Objectives and hypotheses: To explore the efficacy and cost-effectiveness of reconsolidation blockade therapy as an adjunct treatment for trauma- and stressor-related disorders as defined in the Diagnostic and Statistical Manual Mental Disorders-5. The investigators hypothesize that, compared to the control group, 5 weekly trauma-memory reactivations under propranolol treatment will confer a significant reduction in trauma-related symptoms and significantly more health-related economic benefits. Stress symptoms and health-related costs will be assessed at 7, 26 and 52 weeks after study inclusion. In this study, the investigators will also explore the effects of reconsolidation blockade with propranolol on various neuropsychological functions.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date March 2023
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Understands and reads French - Currently or previously worked for the Quebec City Police Department, or the 911 dispatch for Quebec City, or another police department or 911 dispatch in the province of Quebec, or for the Quebec Ministry of Public Security as a correctional service officer - Meets criteria for a trauma-and stressor-related disorder, such as: Acute Stress Disorder, Posttraumatic Stress Disorder, Adjustment Disorder, Other Trauma- and Stressor-Related Disorder, as defined by the Diagnostic and Statistical Manual for Mental Disorders, 5th edition. - The trauma-and stressor-related disorder must be due to a work-related event. - A score of at least 4 (moderately ill) on the Clinical Global Impressions-Severity Scale. - Participants who are currently taking a Selective Serotonin Reuptake Inhibitors or Selective Norepinephrine Reuptake Inhibitors (antidepressants) must accept to skip their morning dose on the days that they receive the study's intervention. Exclusion Criteria: - Systolic blood pressure < 100mm Hg (millimeter of mercury) at visit 0. - Heart rate < 55 bpm (beats per minute) at visit 0. - Medical conditions that contraindicate propranolol administration, as determined by the treating physician. - Previous diagnosis of a traumatic brain injury (TBI). - Previous adverse reaction or non-compliance with a beta-blocker. - Medications that can have an dangerous interaction with propranolol. - Fertile women who are not using an adequate contraceptive methods. - Pregnant women. - Nursing women. - The following psychiatric conditions: past or present bipolar disorder, past or present psychotic disorder, present substance abuse or dependence, actively suicidal, past or present neurological disorder, complex posttraumatic stress disorder.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Propranolol Hydrochloride
1mg / kg of propranolol hydrochloride, oral capsule
Placebo
1mg / kg of matched placebo, oral capsule

Locations

Country Name City State
Canada Douglas Mental Health University Institute Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Douglas Mental Health University Institute Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Social Functioning Questionnaire (SFQ) Measure of psycho-social functional Change from baseline (week 0) to weeks 7, 26, and 52.
Other Rey's 15-Item Memory test Measure of verbal learning and memory Change from baseline (week 0) to weeks 7 and 52.
Other The Logical Memory subtest of the Wechsler Memory Scale - III Measure of verbal learning and memory Change from baseline (week 0) to weeks 7 and 52.
Other Trail Making Test Measure of mental flexibility Change from baseline (week 0) to weeks 7 and 52.
Other Color-Word Interference Test of the Delis-Kaplan Executive Function System Measure of selective attention Change from baseline (week 0) to weeks 7 and 52.
Other Coding subtest of the Wechsler Adult Intelligence Scale-IV Measure of working memory Change from baseline (week 0) to weeks 7 and 52.
Other Attention subtest of the Paced Auditory Serial Addition Test (PASAT) Measure of working memory, divided attention, and information processing speed Change from baseline (week 0) to weeks 7 and 52.
Other D2 Test of attention Measure of selective and sustained attention Change from baseline (week 0) to weeks 7 and 52.
Other Verbal Fluency Test Measure of verbal ability and executive control Change from baseline (week 0) to weeks 7 and 52.
Other Subjective Units of Distress Scale Measure of subjective distress from exposure to an event Changes from week 1 to weeks 2, 3, 4 and 5.
Primary EuroQol five dimensions questionnaire with five-level scale This questionnaire is a standardized instrument for measuring generic health status The weighted average of the questionnaire responses will be calculated over a 12 month period
Secondary Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5) Measure of trauma and stressor related symptoms Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Secondary Hopkins Symptom Checklist - 25 (HSCL - 25). Measure of depression and anxiety symptom severity Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Secondary Operational Police Stress Questionnaire (PSQ-OP) Measure of severity of occupational stress Change from baseline (week 0) to weeks 7, 26, and 52.
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