NCT04965740

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

July 4, 2021

Last Update Submit

August 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

North American First Responders

Spread directly to union representatives for email and messaging to those interested in taking the survey

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.

Drug: Cannabis

Interventions

Recreational Cannabis

Also known as: Recreational Cannabis
North American First RespondersOceana and European first responders

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

Related 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. doi: 10.1159/000054884.

    PMID: 11287794BACKGROUND
  • 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.

    PMID: 16891557BACKGROUND
  • 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.

    PMID: 32500209BACKGROUND
  • 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.

    PMID: 22736575BACKGROUND
  • 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.

    PMID: 24594678BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepressionDepressive Disorder

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorMood Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 16, 2021

Study Start

June 4, 2021

Primary Completion

February 4, 2022

Study Completion

February 15, 2022

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations