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Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410913
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Keith Heinzerling, Saint John's Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date January 31, 2022
Actual Study Start Date  ICMJE February 18, 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Feasibility: Recruitment Rate [ Time Frame: Week 10 ]
    Enroll at least 70% of target number of participants
  • Feasibility: Retention Rate [ Time Frame: week 10 ]
    Participants complete at least 70% of post-randomization visits
  • Tolerability: Number of Visual Healing segments viewed by participants [ Time Frame: Week 7 ]
    Average number of segments viewed
  • Safety/Tolerability: number of Adverse Events [ Time Frame: Week 14 ]
    Average number of adverse events (side effects)
  • Safety: Systolic Blood Pressure [ Time Frame: Week 14 ]
    Systolic blood pressure during dosing sessions
  • Safety: Diastolic Blood Pressure [ Time Frame: Week 14 ]
    Diastolic blood pressure during dosing sessions
  • Safety: Heart rate [ Time Frame: Week 14 ]
    Heart rate during dosing sessions
  • Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score [ Time Frame: Week 14 ]
    Average change in anxiety scale score from prep session to dosing session
  • Safety: Challenging Experience Questionnaire (CEQ) [ Time Frame: Week 14 ]
    Average score on challenging psychedelic experience scale
  • Safety: Questionnaire for Psychotic Experiences [ Time Frame: Week 14 ]
    Average score on psychosis symptom scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder
Official Title  ICMJE Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Psilocybin plus Visual Healing Set and Setting
  • 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.
    Intervention: Drug: Psilocybin plus Standard Set and Setting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04410913
Other Study ID Numbers  ICMJE PTRIP002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Keith Heinzerling, Saint John's Cancer Institute
Study Sponsor  ICMJE Keith Heinzerling
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Saint John's Cancer Institute
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP