Recruiting
Phase 2

Observational Study

Sponsor:

Douglas Mental Health University Institute

Code:

NCT03152175

Conditions

Trauma and Stressor Related Disorders

Post-traumatic Stress Disorders

Adjustment Disorders

Acute Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Propranolol Hydrochloride

Placebo

Study Details

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

Study ID

NCT03152175

Start date

Mar 30, 2017

Status verified date

Jun, 2021

Completion date

Mar, 2023

Anticipated

Primary completion date

Mar, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Propranolol Hydrochloride

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

placebo comparator: Placebo

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

Interventions

Propranolol Hydrochloride

1mg / kg of propranolol hydrochloride, oral capsule

Placebo

1mg / kg of matched placebo, oral capsule

Primary outcome measure

  • EuroQol five dimensions questionnaire with five-level scale [ Time Frame: The weighted average of the questionnaire responses will be calculated over a 12 month period ]

Central Contacts and Locations

Central contacts

Alain Brunet, PhD.

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

Daniel Saumier, PhD.

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

Locations

Douglas Mental Health University Institute

Recruiting

Montreal, Quebec, Canada, H4H1R3

Contacts

Daniel Saumier

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

Principal Investigator:

Alain Brunet, PhD.

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

Jun 18, 2021

Last verified

Jun, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2021-06-18.