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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

Tracking Information
First Submitted Date August 30, 2021
First Posted Date September 13, 2021
Last Update Posted Date September 27, 2021
Actual Study Start Date September 16, 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Entheogen Resurgence
Official Title Entheogen Resurgence - Surveying Entheogen Retreat Participants in Naturalistic Settings
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psychedelic Experiences
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 6, 2021)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Olivia M Uhley, BA 402-819-8955 oliviauhley@resurgentbiosciences.com
Contact: Stephen Dahmer, MD 612-999-1606 stephendahmer@vireohealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05042765
Other Study ID Numbers #2021-61137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Vireo Health
Study Sponsor Vireo Health
Collaborators Not Provided
Investigators
Principal Investigator: Stephen Dahmer, ND Resurgent Biosciences, Inc.
PRS Account Vireo Health
Verification Date September 2021