Trauma and Stressor Related DisordersPhase 2NCT03152175
Posttraumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators
A Phase 2 study testing Propranolol Hydrochloride in people with Trauma and Stressor Related Disorders and Post-traumatic Stress Disorders, run by Douglas Mental Health University Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma and Stressor Related Disorders, Post-traumatic Stress Disorders, Adjustment Disorders
- What is being tested?
- Propranolol Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2017to Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Douglas Mental Health University Institute
Montreal, Quebec, H4H1R3
Daniel Saumier, 514-761-6131 ext. 4349, irsst.brunet@gmail.com
Alain Brunet, PhD.
About this study
Official title: Post-traumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators: A Cost-effectiveness and Efficacy Comparison of Treatment as Usual and a Novel Intervention
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
- Being tested
- Propranolol Hydrochloride, Placebo
- Keywords
- Memory Reconsolidation, Propranolol, Police officers, 911 operators, Efficacy, Cost-effectiveness
- Medical subject headings
- Trauma and Stressor Related Disorders, Stress Disorders, Post-Traumatic, Adjustment Disorders, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Also called Teva-propranolol
1mg / kg of propranolol hydrochloride, oral capsule
PlaceboDrug
1mg / kg of matched placebo, oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Propranolol Hydrochloride | Experimental | 1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol five dimensions questionnaire with five-level scale
This questionnaire is a standardized instrument for measuring generic health status
Measured: 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)
Measure of trauma and stressor related symptoms
Measured: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Hopkins Symptom Checklist - 25 (HSCL - 25).
Measure of depression and anxiety symptom severity
Measured: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Operational Police Stress Questionnaire (PSQ-OP)
Measure of severity of occupational stress
Measured: Change from baseline (week 0) to weeks 7, 26, and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start30 Mar 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated measures parallel design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
- Responsible party
- Principal investigator, Alain Brunet, Ph.D., Douglas Mental Health University Institute
- Investigators
- Alain Brunet, PhD., Principal investigator, Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152175
- Sponsor's protocol ID
- PRPL-007
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators: A Cost-effectiveness and Efficacy Comparison of Treatment as Usual and a Novel Intervention
- ClinicalTrials.gov ID
- NCT03152175
- Acronym / sponsor ID
- PRPL-007
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Repeated measures parallel design.
| Arm | Type | Receives |
|---|---|---|
| Propranolol Hydrochloride | Experimental | Drug: Propranolol Hydrochloride1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol HydrochlorideAlso: Teva-propranolol1mg / kg of propranolol hydrochloride, oral capsule | Drug | Propranolol Hydrochloride |
| Placebo1mg / kg of matched placebo, oral capsule | Drug | Placebo |
Primary outcome
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
This questionnaire is a standardized instrument for measuring generic health status
3 secondary outcomes
Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)
Time frame: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Hopkins Symptom Checklist - 25 (HSCL - 25).
Time frame: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Operational Police Stress Questionnaire (PSQ-OP)
Time frame: Change from baseline (week 0) to weeks 7, 26, and 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Brunet, PhD. principal investigator
Douglas Mental Health University Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol Hydrochloride in people with Trauma and Stressor Related Disorders and Post-traumatic Stress Disorders, run by Douglas Mental Health University Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Brunet, PhD. (514-761-6131 ext. 4348, alain.brunet@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.