Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05042765
Other study ID # #2021-61137
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 16, 2021
Est. completion date January 12, 2022

Study information

Verified date January 2022
Source Vireo Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For the purpose of this anonymous, observational pilot survey, the investigators will define "entheogens" as substances, generally derived from plants, that are ingested in order to impact one's consciousness for therapeutic, religious, or spiritual purposes. This survey will focus on the naturalistic use of entheogens and other substances including kambo, ayahuasca, hapé, bufo, and sananga typically used in specific cultural and spiritual contexts for healing. There are substantial limitations to what the healthcare community knows about the intentions, motivations, experiences, health behaviors, and demographics of people who decide to participate in entheogen therapy centers or retreats and their willingness to participate in future research studies. The primary goal of this observational pilot survey is to collect self-reported, anonymous data from people who have opted to participate in entheogen therapy centers and retreats during the last five (5) years on the topics of their initial intentions, motivations, experiences, demographics, and willingness to participate in future entheogen research. With the support of established therapy and retreat centers, the research team will aim to collect 100 survey responses from unique, unidentified individuals who have participated in some form of entheogen therapy or treatment during the last five (5) years. Those who choose to fill out the survey will be at least 18 years of age, fluent in English, and self-reporting participation in therapy or a retreat which utilized entheogens in a naturalistic setting in the past five (5) years.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date January 12, 2022
Est. primary completion date January 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 years old - Fluent in English - Self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years Exclusion Criteria: - Inability to provide informed consent - Inability to complete the online questionnaire - No self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years - Self-reported participation in therapy or a retreat in naturalistic setting that incorporated the use of entheogens greater than five (5) years ago

Study Design


Related Conditions & MeSH terms


Intervention

Other:
self-reported entheogen use
self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years

Locations

Country Name City State
United States Vireo Health of New York Queens New York

Sponsors (1)

Lead Sponsor Collaborator
Vireo Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Entheogen Use in Naturalistic Retreat & Therapeutic Settings The primary outcome will be self-reported experiences related to entheogen use in naturalistic retreat and therapeutic settings. Entheogen use will have occured within the last 5 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05468047 - Ketamine Therapy Experiential Education Study Early Phase 1
Enrolling by invitation NCT05592379 - Consciousness, Psilocybin, and Well-Being Phase 1
Completed NCT04842045 - Pilot RECAP Study in Healthy Volunteers Phase 1
Completed NCT04965740 - Exploring Medically Perceived Benefits, Use and Interest in Psychedelics and Cannabinoids
Not yet recruiting NCT06450210 - Safety for Home Administration of Microdose Psilocybin Use Phase 1
Recruiting NCT05698511 - Neural and Physiological Correlates of Psychedelic Sub-states Phase 1
Withdrawn NCT05252598 - Mood and Cognitive Effects of Psilocybin in Healthy Participants Early Phase 1
Terminated NCT04424225 - Visual Surround Suppression and Perceptual Expectation Under Psilocybin Phase 1
Not yet recruiting NCT05866471 - Pairing Psilocybin With Transcutaneous Auricular Vagus Nerve Stimulation Phase 1