Posttraumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators

NCT03152175 | Unknown Phase 2 DMC

• 1 other identifier: PRPL-007
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma and Stressor Related Disorders; Post-traumatic Stress Disorders; Adjustment Disorders; Acute Stress Disorder

Keywords

Memory Reconsolidation; Propranolol; Police officers; 911 operators; Efficacy; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)

  Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.

• Hopkins Symptom Checklist - 25 (HSCL - 25).

  Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.

• Operational Police Stress Questionnaire (PSQ-OP)

  Change from baseline (week 0) to weeks 7, 26, and 52.

Other Outcomes (10)

• Social Functioning Questionnaire (SFQ)

  Change from baseline (week 0) to weeks 7, 26, and 52.

• Rey's 15-Item Memory test

  Change from baseline (week 0) to weeks 7 and 52.

• The Logical Memory subtest of the Wechsler Memory Scale - III

  Change from baseline (week 0) to weeks 7 and 52.

Study Arms (2)

Propranolol Hydrochloride

EXPERIMENTAL

1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation

Drug: Propranolol Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation

Drug: Placebo

Interventions

Propranolol Hydrochloride DRUG

1mg / kg of propranolol hydrochloride, oral capsule

Also known as: Teva-propranolol

Propranolol Hydrochloride

Placebo DRUG

1mg / kg of matched placebo, oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail: collaborator

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H1R3, Canada

RECRUITING

MeSH Terms

Conditions

Trauma and Stressor Related Disorders; Stress Disorders, Post-Traumatic; Adjustment Disorders; Stress Disorders, Traumatic, Acute

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Alain Brunet, PhD.

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Brunet, PhD.

CONTACT

514-761-6131; alain.brunet@mcgill.ca

Daniel Saumier, PhD.

CONTACT

514-761-6131; irsst.brunet@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Full Professor, Department of Psychiatry, McGill University.

Model Details: Repeated measures parallel design.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: May 12, 2017
• Study Start: March 30, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

CA (1)