- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04965740
Exploring Medically Perceived Benefits, Use and Interest in Psychedelics and Cannabinoids (EMPOWER)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Centre for Neurology Studies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
North American First Responders
Spread directly to union representatives for email and messaging to those interested in taking the survey
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Recreational Cannabis
Other Names:
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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.
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Recreational Cannabis
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collect Insights from First Responders
Time Frame: 8 months
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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.
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8 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Marmar 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.
- Jerome 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.
- Passie 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.
- Gasser 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMP-SURVEY-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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