Study NCT04410913
Pilot Trial of Visual HealingĀ® in Psilocybin-assisted Therapy for Alcohol Use Disorder
Submitted Date:  September 19, 2023 (v6)
Quality Control Review Has Not Concluded

Note: The results information displayed below has not completed the quality control (QC) review process. ClinicalTrials.gov must post results information for applicable clinical trials (ACTs) within 30 days of submission, even if the submission has not completed the QC review process. The study sponsor or investigator is responsible for ensuring the results information meets the QC review criteria.

This submission includes brief standardized QC review comments added by the National Library of Medicine (NLM). These comments indicate the location of apparent errors, deficiencies, or inconsistencies. For more information, see the Final Rule (42 CFR Part 11) Information page.


Open or close this module Study Identification
Unique Protocol ID: PTRIP002
Brief Title: Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder
Official Title: Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2023
Overall Status: Completed
Study Start: February 18, 2021
Primary Completion: April 29, 2022 [Actual]
Study Completion: April 29, 2022 [Actual]
First Submitted: May 18, 2020
First Submitted that
Met QC Criteria:
May 28, 2020
First Posted: June 1, 2020 [Actual]
Results First Submitted: September 19, 2023
Results First Submitted that
Met QC Criteria:
Results First Posted: October 13, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: October 13, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Keith Heinzerling
Responsible Party: Sponsor-Investigator
Investigator: Keith Heinzerling
Official Title: Director, Pacific Treatment & Research In Psychedelics Program
Affiliation: Saint John's Cancer Institute
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The purpose of this study is to evaluate the feasibility, safety, and tolerability of adding Visual Healing, a nature-themed virtual immersive program, to psilocybin-assisted therapy among participants with alcohol use disorder.
Detailed Description: The objective of the study is to test a strategy for optimizing Set and Setting for psilocybin-assisted therapy of alcohol use disorder. Psilocybin shows promise in early trials for alcohol use disorder, but initial results suggest that patients with alcohol use disorder may be less likely to achieve a mystical experience with standard doses of psilocybin. Optimizing Set and Setting for the psilocybin experience may improve outcomes without requiring higher drug doses. The current study will complete a pilot randomized clinical trial to assess the feasibility, safety, and tolerability of Visual Healing Set and Setting (N=10) versus standard Set and Setting procedures (N=10) in participants with alcohol use disorder undergoing open-label psilocybin 25 mg therapy. In the Visual Healing condition, participants will view nature-themed video programs during the Prep session and during the Ascent phase of the psilocybin experience. Anecdotal reports and reviews suggest that viewing Visual Healing creates a tranquil and calming environment that fosters a stronger connection between the viewer and nature. Psilocybin increases the users feeling of connection to nature and having an intention to connect with nature during the psychedelic session is associated with better outcomes of psychedelic-assisted therapy in initial studies. Reducing pre-dosing anxiety/apprehension and enhancing connections to nature with Visual Healing may improve outcomes of psychedelic-assisted therapy without the need for higher psilocybin doses.
Open or close this module Conditions
Conditions: Alcohol Use Disorder
Keywords: Psilocybin
Psychedelics
Alcohol Use Disorder
Alcoholism
Psychedelic-assisted Therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Parallel assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 20 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Visual Healing Set and Setting
Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.
Drug: Psilocybin plus Visual Healing Set and Setting
Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).
Active Comparator: Standard Set and Setting
Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.
Drug: Psilocybin plus Standard Set and Setting
Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Feasibility: Recruitment Rate
[ Time Frame: Week 3 ]

Enroll at least 70% of target number of participants
2. Feasibility: Retention Rate
[ Time Frame: week 10 ]

Participants complete at least 70% of post-randomization visits
3. Tolerability: Number of Visual Healing Minutes Viewed by Participants
[ Time Frame: Week 7 ]

Average number of minutes viewed in opening video
4. Safety/Tolerability: Number of Adverse Events
[ Time Frame: Week 1-14 ]

Average number of adverse events (side effects) rated as possibly, probably or definitely related to study interventions.
5. Safety: Systolic Blood Pressure Mean Peak Change
[ Time Frame: Week 3 ]

Average peak change in systolic blood pressure from pre-dose to post-dose administration
6. Safety: Diastolic Blood Pressure Mean Peak Change
[ Time Frame: Week 3 ]

Average peak change in diastolic blood pressure from pre-dose to post-dose administration
7. Safety: Heart Rate Mean Peak Change
[ Time Frame: Week 3 ]

Average peak change in heart rate from pre-dose to post-dose administration
8. Tolerability: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) Mean Change
[ Time Frame: Week 3 - 3.1 ]

Average change in anxiety scale total score from pre-dose to post-dose. Higher score indicates more anxiety.

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
9. Safety: Challenging Experience Questionnaire (CEQ) Mean Score
[ Time Frame: Week 3 ]

Average score on challenging psychedelic experience scale

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
10. Safety: Questionnaire for Psychotic Experiences Mean Change
[ Time Frame: Week 0 - 6 ]

Average change from week 0 baseline to week 6 in total psychosis symptom scale score

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age 18 or older
  • Able to read, speak, and understand English
  • Alcohol use disorder, moderate-severe, according to DSM-5 criteria
  • Interested in stopping or reducing alcohol use
  • Able and willing to adhere to study requirements, including attending all study visits, preparatory, and follow-up sessions, and completing all study evaluations
  • Able to swallow capsules
  • Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study
  • Have an identified support person
  • Agree to be driven home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing

Exclusion Criteria:

  • Alcohol withdrawal requiring medical intervention
  • Women who are pregnant, or women who intend to become pregnant during the study or who are currently nursing
  • Unwilling or unable to discontinue formal alcohol use disorder treatment
  • Significant current or history of cardiovascular condition
  • Have a history of stroke or Transient Ischemic Attack (TIA)
  • Moderate to severe liver impairment
  • Epilepsy
  • Insulin-dependent diabetes
  • Diabetes and taking oral hypoglycemic agent with a history of hypoglycemia requiring serious medical intervention
Open or close this module Contacts/Locations
Locations: United States, California
Pacific Treatment & Research in Psychedelics
Santa Monica, California, United States, 90404
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13. PubMed 25586396
Bogenschutz MP, Podrebarac SK, Duane JH, Amegadzie SS, Malone TC, Owens LT, Ross S, Mennenga SE. Clinical Interpretations of Patient Experience in a Trial of Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder. Front Pharmacol. 2018 Feb 20;9:100. doi: 10.3389/fphar.2018.00100. eCollection 2018. PubMed 29515439
Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6. PubMed 28353056
Carbonaro TM, Bradstreet MP, Barrett FS, MacLean KA, Jesse R, Johnson MW, Griffiths RR. Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. J Psychopharmacol. 2016 Dec;30(12):1268-1278. doi: 10.1177/0269881116662634. Epub 2016 Aug 30. PubMed 27578767
Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8. PubMed 29119217
Dos Santos RG, Bouso JC, Alcazar-Corcoles MA, Hallak JEC. Efficacy, tolerability, and safety of serotonergic psychedelics for the management of mood, anxiety, and substance-use disorders: a systematic review of systematic reviews. Expert Rev Clin Pharmacol. 2018 Sep;11(9):889-902. doi: 10.1080/17512433.2018.1511424. Epub 2018 Aug 23. PubMed 30102078
Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513. PubMed 27909165
Hasler F, Bourquin D, Brenneisen R, Bar T, Vollenweider FX. Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharm Acta Helv. 1997 Jun;72(3):175-84. doi: 10.1016/s0031-6865(97)00014-9. PubMed 9204776
Johnson M, Richards W, Griffiths R. Human hallucinogen research: guidelines for safety. J Psychopharmacol. 2008 Aug;22(6):603-20. doi: 10.1177/0269881108093587. Epub 2008 Jul 1. PubMed 18593734
Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y. PubMed 28585222
Johnson MW, Griffiths RR, Hendricks PS, Henningfield JE. The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act. Neuropharmacology. 2018 Nov;142:143-166. doi: 10.1016/j.neuropharm.2018.05.012. Epub 2018 Jun 5. PubMed 29753748
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: April 12, 2021
Uploaded: 08/30/2023 22:40
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: July 19, 2022
Uploaded: 08/30/2023 22:49
File Name: SAP_001.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details
 
Arm/Group Title Visual Healing Set and Setting Standard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Period Title: Overall Study
Started 10 10
Completed 10 9
Not Completed 0 1
Reason Not Completed
Physician Decision 0 1
Open or close this module Baseline Characteristics
Arm/Group TitleVisual Healing Set and SettingStandard Set and SettingTotal
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Baseline Analysis Population Description [Not Specified]
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed10 Participants10 Participants20 Participants
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
10
100%
9
90%
19
95%
>=65 years
0
0%
1
10%
1
5%
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed10 Participants10 Participants20 Participants
46.9(8.5)51.0(13.2)48.95(10.99)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed10 Participants10 Participants20 Participants
Female
6
60%
6
60%
12
60%
Male
4
40%
4
40%
8
40%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed10 Participants10 Participants20 Participants
Hispanic or Latino
1
10%
1
10%
2
10%
Not Hispanic or Latino
9
90%
9
90%
18
90%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed10 Participants10 Participants20 Participants
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
White
9
90%
10
100%
19
95%
More than one race
1
10%
0
0%
1
5%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed10 Participants10 Participants20 Participants
United States
101020
Open or close this module Outcome Measures
1. Primary Outcome:
Title Feasibility: Recruitment Rate
Description Enroll at least 70% of target number of participants
Time Frame Week 3
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
100%
10
100%
2. Primary Outcome:
Title Feasibility: Retention Rate
Description Participants complete at least 70% of post-randomization visits
Time Frame week 10
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
100%
9
90%
3. Primary Outcome:
Title Tolerability: Number of Visual Healing Minutes Viewed by Participants
Description Average number of minutes viewed in opening video
Time Frame Week 7
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed6 6
Mean (Standard Deviation)
Unit of Measure: minutes viewed
19.8(18.6) 24.0(19.4)
4. Primary Outcome:
Title Safety/Tolerability: Number of Adverse Events
Description Average number of adverse events (side effects) rated as possibly, probably or definitely related to study interventions.
Time Frame Week 1-14
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Measure Type: Number
Unit of Measure: adverse events
23
230%
40
400%
5. Primary Outcome:
Title Safety: Systolic Blood Pressure Mean Peak Change
Description Average peak change in systolic blood pressure from pre-dose to post-dose administration
Time Frame Week 3
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
19.61(13.37) 29.16(18.74)
6. Primary Outcome:
Title Safety: Diastolic Blood Pressure Mean Peak Change
Description Average peak change in diastolic blood pressure from pre-dose to post-dose administration
Time Frame Week 3
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
10.67(7.03) 12.16(7.29)
7. Primary Outcome:
Title Safety: Heart Rate Mean Peak Change
Description Average peak change in heart rate from pre-dose to post-dose administration
Time Frame Week 3
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Mean (Standard Deviation)
Unit of Measure: beats per minute
2.89(8.17) 8.95(8.88)
8. Primary Outcome:
Title Tolerability: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) Mean Change
Description Average change in anxiety scale total score from pre-dose to post-dose. Higher score indicates more anxiety.
Time Frame Week 3 - 3.1

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Mean (Standard Error)
Unit of Measure: total score
3.8(2.13) 5.3(2.13)
9. Primary Outcome:
Title Safety: Challenging Experience Questionnaire (CEQ) Mean Score
Description Average score on challenging psychedelic experience scale
Time Frame Week 3

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Mean (Standard Deviation)
Unit of Measure: Total score
0.2(0.1) 0.3(0.2)
10. Primary Outcome:
Title Safety: Questionnaire for Psychotic Experiences Mean Change
Description Average change from week 0 baseline to week 6 in total psychosis symptom scale score
Time Frame Week 0 - 6

Quality Control Review Comment provided by the National Library of Medicine:

  1. The description of the scale or categories does not include sufficient information to understand the results reported.
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group TitleVisual Healing Set and SettingStandard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Overall Number of Participants Analyzed10 10
Mean (Standard Deviation)
Unit of Measure: total score
-0.2(1.0) -0.1(0.3)
Open or close this module Adverse Events
 
Time Frame Adverse events assessed at every study visit, starting at Week 0 Screening up until the final Week 14 visit. With a 30-day screening window, the specific time period was 15 weeks.
Adverse Event Reporting Description [Not specified]
 
Arm/Group Title Visual Healing Set and Setting Standard Set and Setting
Arm/Group Description

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Visual Healing Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling.

Psilocybin plus Standard Set and Setting: Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).

All-Cause Mortality
  Visual Healing Set and SettingStandard Set and Setting
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 0 / 10 (0%)0 / 10 (0%)
Serious Adverse Events
  Visual Healing Set and SettingStandard Set and Setting
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 0 / 10 (0%)1 / 10 (10%)
Psychiatric disorders
Alcohol Relapse Requiring Inpatient Detoxification 0 / 10 (0%)01 / 10 (10%)2
Indicates events were collected by systematic assessment.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  Visual Healing Set and SettingStandard Set and Setting
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 10 / 10 (100%)10 / 10 (100%)
Blood and lymphatic system disorders
Anemia 1 / 10 (10%)11 / 10 (10%)1
Cardiac disorders
Bradycardia 1 / 10 (10%)11 / 10 (10%)1
EKG Abnormality 2 / 10 (20%)20 / 10 (0%)0
Elevated Blood Pressure 2 / 10 (20%)55 / 10 (50%)9
Low Blood Pressure 1 / 10 (10%)10 / 10 (0%)0
Tachycardia 0 / 10 (0%)01 / 10 (10%)4
Gastrointestinal disorders
Abdominal Pain 0 / 10 (0%)01 / 10 (10%)1
Diarrhea 1 / 10 (10%)10 / 10 (0%)0
Gastroenteritis 0 / 10 (0%)01 / 10 (10%)1
Nausea 2 / 10 (20%)23 / 10 (30%)6
Vomiting 1 / 10 (10%)10 / 10 (0%)0
General disorders
Body Aches 0 / 10 (0%)01 / 10 (10%)2
Fever 0 / 10 (0%)01 / 10 (10%)1
Wooziness 0 / 10 (0%)01 / 10 (10%)1
Infections and infestations
COVID Infection 1 / 10 (10%)11 / 10 (10%)1
Urinary Tract Infection 0 / 10 (0%)01 / 10 (10%)1
Musculoskeletal and connective tissue disorders
Flank Pain 0 / 10 (0%)01 / 10 (10%)1
Fractured Foot 1 / 10 (10%)10 / 10 (0%)0
Jaw Clenching/Pain 0 / 10 (0%)01 / 10 (10%)1
Joint Pain 1 / 10 (10%)10 / 10 (0%)0
Knee Pain 1 / 10 (10%)10 / 10 (0%)0
Low Back Pain 1 / 10 (10%)11 / 10 (10%)1
Tinnitus 0 / 10 (0%)01 / 10 (10%)1
Nervous system disorders
Headache 4 / 10 (40%)57 / 10 (70%)11
Tremor 1 / 10 (10%)10 / 10 (0%)0
Twitching 2 / 10 (20%)23 / 10 (30%)3
Psychiatric disorders
Anxiety 2 / 10 (20%)31 / 10 (10%)1
Depressed Mood 0 / 10 (0%)01 / 10 (10%)1
Elevated Blood Alcohol Level 0 / 10 (0%)01 / 10 (10%)1
Insomnia 1 / 10 (10%)13 / 10 (30%)3
Irritable Mood 1 / 10 (10%)10 / 10 (0%)0
Panick Attack 1 / 10 (10%)11 / 10 (10%)1
Synesthesia 0 / 10 (0%)01 / 10 (10%)1
Vivid Dreams 0 / 10 (0%)02 / 10 (20%)2
Respiratory, thoracic and mediastinal disorders
Nasal Congestion 1 / 10 (10%)10 / 10 (0%)0
Skin and subcutaneous tissue disorders
Feeling flushed 2 / 10 (20%)30 / 10 (0%)0
Skin Cancer 1 / 10 (10%)10 / 10 (0%)0
Indicates events were collected by systematic assessment.
Open or close this module Limitations and Caveats
This was a pilot trial with a small sample size testing the feasibility of incorporating a nature-themed video within a psilocybin session. Psilocybin was open-label and there was no placebo group and the study did not test whether psilocybin is effective for treating alcohol use disorder.
Open or close this module More Information
Certain Agreements:
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact:
Name/Official Title:
Keith Heinzerling MD
Organization:
Pacific Neuroscience Institute TRIP
Phone:
13105827611
Email:
keith.heinzerling@providence.org

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