PTSDEMPOWERNCT04965740
Exploring Medically Perceived Benefits, Use and Interest in Psychedelics and Cannabinoids
An observational study of PTSD and Anxiety, run by Empower Research Inc at 1 site in Canada.
Trial summary
The primary objective of this study is to collect insights from first responders and military personnel on their need for, use of, and interest in physical and/or mental health medical marijuana or psychedelic-assisted therapy programs. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Anxiety, Anxiety Disorders
- What is being tested?
- Cannabis
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2021to 15 Feb 2022
- Phase
- Observational
- 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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 10,000 first responders and/or military personnel will be asked to participate in the survey. Assuming a 20-30% response rate, the investigators expect approximately 2500 individual responses.
Who may be able to join
- Adult (19+) first responders and military personnel in Canada, USA, Oceana and Europe -
- Not restricted by restricted by sex, gender, or diagnoses.
- Respondents must be able to read and write in English to participate.
Who cannot join
- Individuals who are not first responders, military personnel, or an aligned profession
- Individuals under the age of 19
- Those who are not able to read and write in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMPOWER Study: Exploring Medically Perceived Benefits, Use and Interest in Psychedelics and Cannabinoids: Observational Study With First Responders and Military Personnel Examining Previous Use Experience and Interest in Participating in Future Research Studies
The primary objective of this study is to collect insights from first responders and military personnel on their need for, use of, and interest in physical and/or mental health medical marijuana or psychedelic-assisted therapy programs. These preliminary data will help to inform and guide the development of a larger patient-oriented study and the design of a clinical program geared towards enhancing therapy treatments for first responders and military personnel.
Read the detailed description
Members of first response teams including police, firefighters, paramedics, and military personnel in Canada, the United States, Oceana, and Europe will be asked to participate. The majority of these teams are unionized, consisting of municipal, provincial and federally organized unions throughout Canada, United States, Oceana and Europe.
Whenever possible, the research team will provide an invitation to its members via union representatives. These unions are a trusted source for first responders and military personnel as they are intended to have the best interests of these first responders in mind. The union representatives possess the contact information of the first responders and military personnel. The unions routinely circulate e-mails to members that include information relevant for members such as upcoming events, important meetings, team activities on and off-duty, and opportunities to participate in research.
Emails with the link to the survey will be circulated to members approximately every month for 3 months, or until at least 1000 participants have responded. The link to the survey may also be shared through personal connections among first responders and/or word of mouth.
Participants will be sent a link to open an anonymous survey which they can complete at their location and time of choosing. Once the survey link has been accessed by a potential participant, background information will be provided regarding the project that includes an informed consent statement. Participants may leave the survey at any time should they wish to discontinue.
The survey will be distributed to first responders and military personnel using an online questionnaire. This survey will contain questions about basic demographics, history of mental health conditions, satisfaction with current life status, past use of cannabis and other psychedelic substances, and interest and potential barriers in trying psychedelic or medical marijuana-assisted physical or mental health therapy in a research or clinical context. The Brief Inventory of Psychosocial Functioning (13) and a subset of questions from the National Institute on Drug Abuse (NIDA) Quick Screen (14) have been integrated into the survey to enhance reliability and validity of results.
The survey will take approximately 15 minutes to complete. Once the survey has been submitted, participants will have the option to click a link to enter their email address using a separate collection form, if they would like to be contacted for future research opportunities.
The list of email addresses will not be linked to the survey results.
Data will be analyzed from all completed (fully or partially) and submitted surveys. Every question will contain a "Prefer Not to Say" option if a response is mandatory.
- Conditions
- PTSD, Anxiety, Anxiety Disorders, Depression, Depressive Disorder, Psychological
- Being tested
- Cannabis
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called Recreational Cannabis
Recreational Cannabis
| Study group | Role | What they receive |
|---|---|---|
| North American First Responders | Spread directly to union representatives for email and messaging to those interested in taking the survey Receives: Drug: Cannabis | |
| Oceana and European first responders | First responder unions and groups that are located outside of North America - particularly Australia, New Zealand, United Kingdom, other commonwealth nations. Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Insights from First Responders
The primary objective of this study is to collect insights from first responders and military personnel on their need for, use of, and interest in physical and/or mental health medical marijuana or psychedelic-assisted therapy programs. These preliminary data will help to inform and guide the development of a larger patient-oriented study and the design of a clinical program geared towards enhancing therapy treatments for first responders and military personnel.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start4 Jun 2021
- Primary completion4 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empower Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965740
- Sponsor's protocol ID
- EMP-SURVEY-001
- Acronym
- EMPOWER
- Status last verified
- Aug 2022
- First submitted
- 4 Jul 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Potentially available for use in planning research with these groups
Publications
Brunello N, Davidson JR, Deahl M, Kessler RC, Mendlewicz J, Racagni G, Shalev AY, Zohar J. Posttraumatic stress disorder: diagnosis and epidemiology, comorbidity and social consequences, biology and treatment. Neuropsychobiology. 2001;43(3):150-62. doi: 10.1159/000054884.
PubMed 11287794Marmar CR, McCaslin SE, Metzler TJ, Best S, Weiss DS, Fagan J, Liberman A, Pole N, Otte C, Yehuda R, Mohr D, Neylan T. Predictors of posttraumatic stress in police and other first responders. Ann N Y Acad Sci. 2006 Jul;1071:1-18. doi: 10.1196/annals.1364.001.
PubMed 16891557Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.
PubMed 32500209Passie T, Emrich HM, Karst M, Brandt SD, Halpern JH. Mitigation of post-traumatic stress symptoms by Cannabis resin: a review of the clinical and neurobiological evidence. Drug Test Anal. 2012 Jul-Aug;4(7-8):649-59. doi: 10.1002/dta.1377. Epub 2012 Jun 26.
PubMed 22736575Gasser P, Holstein D, Michel Y, Doblin R, Yazar-Klosinski B, Passie T, Brenneisen R. Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. J Nerv Ment Dis. 2014 Jul;202(7):513-20. doi: 10.1097/NMD.0000000000000113.
PubMed 24594678
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER Study: Exploring Medically Perceived Benefits, Use and Interest in Psychedelics and Cannabinoids: Observational Study With First Responders and Military Personnel Examining Previous Use Experience and Interest in Participating in Future Research Studies
- ClinicalTrials.gov ID
- NCT04965740
- Acronym / sponsor ID
- EMPOWER / EMP-SURVEY-001
- Conditions
- PTSD, Anxiety, Anxiety Disorders, Depression, Depressive Disorder, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Empower Research IncIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 16 Jul 2021 (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.
The primary objective of this study is to collect insights from first responders and military personnel on their need for, use of, and interest in physical and/or mental health medical marijuana or psychedelic-assisted therapy programs. These preliminary data will help to inform and guide the development of a larger patient-oriented study and the design of a clinical program geared towards enhancing therapy treatments for first responders and military personnel.
Detailed description
Members of first response teams including police, firefighters, paramedics, and military personnel in Canada, the United States, Oceana, and Europe will be asked to participate. The majority of these teams are unionized, consisting of municipal, provincial and federally organized unions throughout Canada, United States, Oceana and Europe.
Whenever possible, the research team will provide an invitation to its members via union representatives. These unions are a trusted source for first responders and military personnel as they are intended to have the best interests of these first responders in mind. The union representatives possess the contact information of the first responders and military personnel. The unions routinely circulate e-mails to members that include information relevant for members such as upcoming events, important meetings, team activities on and off-duty, and opportunities to participate in research.
Emails with the link to the survey will be circulated to members approximately every month for 3 months, or until at least 1000 participants have responded. The link to the survey may also be shared through personal connections among first responders and/or word of mouth.
Participants will be sent a link to open an anonymous survey which they can complete at their location and time of choosing. Once the survey link has been accessed by a potential participant, background information will be provided regarding the project that includes an informed consent statement. Participants may leave the survey at any time should they wish to discontinue.
The survey will be distributed to first responders and military personnel using an online questionnaire. This survey will contain questions about basic demographics, history of mental health conditions, satisfaction with current life status, past use of cannabis and other psychedelic substances, and interest and potential barriers in trying psychedelic or medical marijuana-assisted physical or mental health therapy in a research or clinical context. The Brief Inventory of Psychosocial Functioning (13) and a subset of questions from the National Institute on Drug Abuse (NIDA) Quick Screen (14) have been integrated into the survey to enhance reliability and validity of results.
The survey will take approximately 15 minutes to complete. Once the survey has been submitted, participants will have the option to click a link to enter their email address using a separate collection form, if they would like to be contacted for future research opportunities.
The list of email addresses will not be linked to the survey results.
Data will be analyzed from all completed (fully or partially) and submitted surveys. Every question will contain a "Prefer Not to Say" option if a response is mandatory.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| North American First Responders | – | Drug: CannabisSpread directly to union representatives for email and messaging to those interested in taking the survey |
| Oceana and European first responders | – | Drug: CannabisFirst responder unions and groups that are located outside of North America - particularly Australia, New Zealand, United Kingdom, other commonwealth nations. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 10,000 first responders and/or military personnel will be asked to participate in the survey. Assuming a 20-30% response rate, the investigators expect approximately 2500 individual responses.
Key inclusion criteria (3 listed)
- Adult (19+) first responders and military personnel in Canada, USA, Oceana and Europe -
- Not restricted by restricted by sex, gender, or diagnoses.
- Respondents must be able to read and write in English to participate.
Key exclusion criteria (3 listed)
- Individuals who are not first responders, military personnel, or an aligned profession
- Individuals under the age of 19
- Those who are not able to read and write in English
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 |
|---|---|---|
| CannabisAlso: Recreational CannabisRecreational Cannabis | Drug | North American First Responders, Oceana and European first responders |
Primary outcome
Collect Insights from First Responders
Time frame: 8 months
The primary objective of this study is to collect insights from first responders and military personnel on their need for, use of, and interest in physical and/or mental health medical marijuana or psychedelic-assisted therapy programs. These preliminary data will help to inform and guide the development of a larger patient-oriented study and the design of a clinical program geared towards enhancing therapy treatments for first responders and military personnel.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Background: PubMed 11287794Brunello N, Davidson JR, Deahl M, Kessler RC, Mendlewicz J, Racagni G, Shalev AY, Zohar J. Posttraumatic stress disorder: diagnosis and epidemiology, comorbidity and social consequences, biology and treatment. Neuropsychobiology. 2001;43(3):150-62. doi: 10.1159/000054884.
- Background: PubMed 16891557Marmar CR, McCaslin SE, Metzler TJ, Best S, Weiss DS, Fagan J, Liberman A, Pole N, Otte C, Yehuda R, Mohr D, Neylan T. Predictors of posttraumatic stress in police and other first responders. Ann N Y Acad Sci. 2006 Jul;1071:1-18. doi: 10.1196/annals.1364.001.
- Background: PubMed 32500209Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.
- Background: PubMed 22736575Passie T, Emrich HM, Karst M, Brandt SD, Halpern JH. Mitigation of post-traumatic stress symptoms by Cannabis resin: a review of the clinical and neurobiological evidence. Drug Test Anal. 2012 Jul-Aug;4(7-8):649-59. doi: 10.1002/dta.1377. Epub 2012 Jun 26.
- Background: PubMed 24594678Gasser P, Holstein D, Michel Y, Doblin R, Yazar-Klosinski B, Passie T, Brenneisen R. Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. J Nerv Ment Dis. 2014 Jul;202(7):513-20. doi: 10.1097/NMD.0000000000000113.
- Survey LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Potentially available for use in planning research with these groups
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Anxiety, run by Empower Research Inc 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 Aug 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect Insights from First Responders (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965740, which also lists 5 linked publications.
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 12 Aug 2022.