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Entheogen Resurgence (SERPNTS)

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ClinicalTrials.gov Identifier: NCT05042765
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Vireo Health

Brief 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.


Condition or disease Intervention/treatment
Psychedelic Experiences Other: self-reported entheogen use

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Entheogen Resurgence - Surveying Entheogen Retreat Participants in Naturalistic Settings
Actual Study Start Date : September 16, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Intervention Details:
  • 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


Primary Outcome Measures :
  1. Entheogen Use in Naturalistic Retreat & Therapeutic Settings [ Time Frame: Entheogen use will have occured within the last 5 years ]
    The primary outcome will be self-reported experiences related to entheogen use in naturalistic retreat and therapeutic settings.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People over the age of 18 years old who are fluent in English and have self-reported participation in entheogen therapy centers or retreats in naturalistic settings during the past five (5) years.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05042765


Contacts
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Contact: Olivia M Uhley, BA 402-819-8955 oliviauhley@resurgentbiosciences.com
Contact: Stephen Dahmer, MD 612-999-1606 stephendahmer@vireohealth.com

Locations
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United States, New York
Vireo Health of New York Recruiting
Queens, New York, United States, 11373
Contact: Stephen Dahmer, MD    612-999-1606    stephendahmer@vireohealth.com   
Contact: Olivia Uhley, BA    402-819-8955    oliviauhley@vireohealth.com   
Sponsors and Collaborators
Vireo Health
Investigators
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Principal Investigator: Stephen Dahmer, ND Resurgent Biosciences, Inc.
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Responsible Party: Vireo Health
ClinicalTrials.gov Identifier: NCT05042765    
Other Study ID Numbers: #2021-61137
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vireo Health:
Entheogen
Psychedelic
Hallucinogen
Kambo
Ayahuasca
Hapé
Bufo
Sananga