Psychedelic ExperiencesSERPNTSNCT05042765
Entheogen Resurgence
An observational study of Psychedelic Experiences, run by Vireo Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychedelic Experiences
- What is being tested?
- self-reported entheogen use
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 12 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Entheogen Resurgence - Surveying Entheogen Retreat Participants in Naturalistic Settings
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.
- Conditions
- Psychedelic Experiences
- Being tested
- self-reported entheogen use
- Keywords
- Entheogen, Psychedelic, Hallucinogen, Kambo, Ayahuasca, Hapé, Bufo, Sananga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-reported entheogen useOther
self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Entheogen use will have occured within the last 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start16 Sep 2021
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychedelic ExperiencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vireo Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Dahmer, ND, Principal investigator, Resurgent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042765
- Sponsor's protocol ID
- #2021-61137
- Acronym
- SERPNTS
- Status last verified
- Jan 2022
- First submitted
- 30 Aug 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entheogen Resurgence - Surveying Entheogen Retreat Participants in Naturalistic Settings
- ClinicalTrials.gov ID
- NCT05042765
- Acronym / sponsor ID
- SERPNTS / #2021-61137
- Conditions
- Psychedelic Experiences
- Keywords
- Entheogen, Psychedelic, Hallucinogen, Kambo, Ayahuasca, Hapé, Bufo, Sananga
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Vireo HealthUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-reported entheogen useself-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Dahmer, ND principal investigator
Resurgent Biosciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychedelic Experiences, run by Vireo Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entheogen Use in Naturalistic Retreat & Therapeutic Settings (time frame: Entheogen use will have occured within the last 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.