Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04965740
Other study ID # EMP-SURVEY-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 4, 2021
Est. completion date February 15, 2022

Study information

Verified date August 2022
Source Empower Research Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date February 15, 2022
Est. primary completion date February 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 85 Years
Eligibility 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 Design


Intervention

Drug:
Cannabis
Recreational Cannabis

Locations

Country Name City State
Canada Centre for Neurology Studies Surrey British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Empower Research Inc

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A

External Links