Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    04410913
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410913
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Keith Heinzerling, John Wayne Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Psilocybin plus Visual Healing Set and Setting Drug: Psilocybin plus Standard Set and Setting Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Feasibility: Recruitment Rate [ Time Frame: Week 10 ]
    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 segments viewed by participants [ Time Frame: Week 7 ]
    Average number of segments viewed

  4. Safety/Tolerability: number of Adverse Events [ Time Frame: Week 14 ]
    Average number of adverse events (side effects)

  5. Safety: Systolic Blood Pressure [ Time Frame: Week 14 ]
    Systolic blood pressure during dosing sessions

  6. Safety: Diastolic Blood Pressure [ Time Frame: Week 14 ]
    Diastolic blood pressure during dosing sessions

  7. Safety: Heart rate [ Time Frame: Week 14 ]
    Heart rate during dosing sessions

  8. 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

  9. Safety: Challenging Experience Questionnaire (CEQ) [ Time Frame: Week 14 ]
    Average score on challenging psychedelic experience scale

  10. Safety: Questionnaire for Psychotic Experiences [ Time Frame: Week 14 ]
    Average score on psychosis symptom scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT04410913


Contacts
Layout table for location contacts
Contact: Keith Heinzerling, MD MPH 310-582-7612 Keith.Heinzerling@providence.org
Contact: Jennifer Bramen, PhD Jennifer.Bramen@providence.org

Locations
Layout table for location information
United States, California
Pacific Treatment & Research in Psychedelics Recruiting
Santa Monica, California, United States, 90404
Contact: Brittany Youssef    310-582-7611    Brittany.Youssef@providence.org   
Sponsors and Collaborators
Keith Heinzerling
Publications:

Layout table for additonal information
Responsible Party: Keith Heinzerling, Director, Pacific Treatment & Research In Psychedelics Program, John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT04410913    
Other Study ID Numbers: PTRIP002
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

Layout table for additional information
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
Keywords provided by Keith Heinzerling, John Wayne Cancer Institute:
Psilocybin
Psychedelics
Alcohol Use Disorder
Alcoholism
Psychedelic-assisted Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs