Psychedelic Therapy for Wellness Studies Retrospectively

NCT05469243 | Unknown DMC FDA Drug

• 1 other identifier: 2022-013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to assess the efficacy psychedelics for improving measures of wellness using a retrospective, single period, cohort study

Conditions

Well Aging

Keywords

wellness; psychedelics

Outcome Measures

Primary Outcomes (1)

• patient's global impression of change

  patient's global impression of change (PGIC) has been used to estimate clinical change with a score of at least (moderate/much better), will be considered the minimally important clinically important difference. Scores 1-7 with higher scores associated with better outcome.

  retrospective used in last 3 years

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale

  baseline (current)

• Pain, Enjoyment and General Activity Scale (PEG)

  baseline (current)

• The Disability Index (DI)

  baseline (current)

Study Arms (1)

psychedelics

50 non active military participants not under the care of Dr. Gupta will be recruited through word of mouth and advertising to self-identify as having used psychedelic medicine for non recreational purposes (Appendix B recruitment letter). In addition to demographic information, they will be asked to complete the PGIC and anxiety, mood, pain and disability subscales, PEG, HADS and DI, provide information on their past medical history, nature/indications for use, and adverse events. This data will be collected once per participant and they will be able to speak with a research associate if further clarification if necessary at anytime.

Drug: Psychedelic

Interventions

Psychedelic DRUG

retrospective survey of previous use

psychedelics

Eligibility Criteria

• Age: 19 Years - 99 Years
• Gender Eligibility Details: man, woman, other
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 non active military participants not under the care of Dr. Gaurav Gupta will be recruited. Colleagues will be informed that have may patients that could be candidates, in addition to advertising on a website and social media (eg facebook, instragram and/or twitter). The catchment will be set to Canada but will be expanded if the recruitment fails. Participants will therefore self-identify as having used psychedelic medicine for non recreational purposes (Appendix B recruitment letter).

You may qualify if:

• Between the ages of 18 - 99
• Self-report of past psychedelic medicine use for therapeutic purposes in the last 3 years
• While a consent letter will be provided, patients will only be asked to agree to the terms without providing their names (i.e., unsigned consent procedures) given the potential legal ramifications of identification
• Civilian or military veterans.

You may not qualify if:

• Past psychedelic medicine use for non- therapeutic purposes
• Only the most recent experience will be commented on
• Active Military Members
• In general patient participation will be anonymous given that access to medication may not have been considered legal. However in cases where there are concerns about a serious health issues and the patient can be identified, they will be to ensure appropriate follow up can be arranged.

Sponsors & Collaborators

• Canadian Forces Health Services Centre Ottawa: lead

Study Sites (1)

Gaurav Gupta MPC

Ottawa, Ontario, K1K4S9, Canada

Location

MeSH Terms

Interventions

Hallucinogens

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Gaurav Gupta

  GG MPC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: July 19, 2022
• Primary Completion: August 18, 2025
• Study Completion: August 27, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)