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

NCT04410913 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: PTRIP002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Psilocybin; Psychedelics; Alcohol Use Disorder; Alcoholism; Psychedelic-assisted Therapy

Outcome Measures

Primary Outcomes (10)

• Feasibility: Recruitment Rate

  Enroll at least 70% of target number of participants

  Week 10

• Feasibility: Retention Rate

  Participants complete at least 70% of post-randomization visits

  week 10

• Tolerability: Number of Visual Healing segments viewed by participants

  Average number of segments viewed

  Week 7

• Safety/Tolerability: number of Adverse Events

  Average number of adverse events (side effects)

  Week 14

• Safety: Systolic Blood Pressure

  Systolic blood pressure during dosing sessions

  Week 14

• Safety: Diastolic Blood Pressure

  Diastolic blood pressure during dosing sessions

  Week 14

• Safety: Heart rate

  Heart rate during dosing sessions

  Week 14

• Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score

  Average change in anxiety scale score from prep session to dosing session

  Week 14

• Safety: Challenging Experience Questionnaire (CEQ)

  Average score on challenging psychedelic experience scale

  Week 14

• Safety: Questionnaire for Psychotic Experiences

  Average score on psychosis symptom scale

  Week 14

Study Arms (2)

Visual Healing Set and Setting

EXPERIMENTAL

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

Standard Set and Setting

ACTIVE COMPARATOR

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

Interventions

Psilocybin plus Visual Healing Set and Setting DRUG

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).

Visual Healing Set and Setting

Psilocybin plus Standard Set and Setting DRUG

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).

Standard Set and Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keith Heinzerling: lead

Study Sites (1)

Pacific Treatment & Research in Psychedelics

Santa Monica, California, 90404, United States

Location

Related Publications (11)

• 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.

  PMID: 25586396 BACKGROUND

• 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.

  PMID: 29515439 BACKGROUND

• 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.

  PMID: 28353056 BACKGROUND

• 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.

  PMID: 27578767 BACKGROUND

• 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.

  PMID: 29119217 BACKGROUND

• 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.

  PMID: 30102078 BACKGROUND

• 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.

  PMID: 27909165 BACKGROUND

• 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.

  PMID: 9204776 BACKGROUND

• 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.

  PMID: 18593734 BACKGROUND

• Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.

  PMID: 28585222 BACKGROUND

• 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.

  PMID: 29753748 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pacific Treatment & Research In Psychedelics Program

Model Details: Parallel assignment

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 1, 2020
• Study Start: February 18, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (1)