Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPsilocybinActive not recruiting

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

Open-label, randomised, Phase II pilot RCT (n=20) comparing psilocybin 25 mg with Visual Healing versus standard set and setting in adults with moderate–severe alcohol use disorder to assess feasibility, safety and tolerability.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

This randomised, open-label, parallel-group pilot trial assigns 20 adults with moderate–severe alcohol use disorder to psilocybin 25 mg plus the Visual Healing set-and-setting platform or psilocybin 25 mg with standard set-and-setting to evaluate feasibility, safety, and tolerability.

Participants receive an initial psilocybin session (25 mg) with assigned set-and-setting and preparatory and integration counselling; four weeks later all participants receive a second 25 mg session where they may choose Visual Healing or standard procedures. Outcomes focus on adverse events, retention, and feasibility metrics.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Visual Healing

experimental

Psilocybin 25 mg with Visual Healing set-and-setting (nature-themed VR/videos) plus prep and integration counselling; second psilocybin session at 4 weeks (participant choice of condition).

Interventions

  • Psilocybin25 mg
    via Oral• two sessions• 2 doses total

    First session with Visual Healing; second session at 4 weeks (participant may choose Visual Healing or standard).

Standard setting

active comparator

Psilocybin 25 mg with standard set-and-setting plus prep and integration counselling; second psilocybin session at 4 weeks (participant choice).

Interventions

  • Psilocybin25 mg
    via Oral• two sessions• 2 doses total

    Standard set-and-setting; second session at 4 weeks (participant may choose Visual Healing or standard).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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

Primary Results(1 publication)

Participants

N = 20Mean age: 46.9–51 across armsG. et al. 2023 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Visual Healingexperimental1023(230.0%)—0(0.0%)0(0.0%)
Standard settingactive_comparator1040(400.0%)—2(20.0%)1(10.0%)

* Table 3 reports frequency of adverse events. Note that 'Overall' in Table 3 refers to the sum of events across both arms. The Visual Healing arm had 23 total reported events (not necessarily unique participants).

* Table 3 reports 40 total reported events for the Standard arm. Two Serious Adverse Events (SAEs) occurred in the Standard group: one alcohol intoxication in Week 2 and one alcohol relapse in Week 6 leading to discontinuation. One participant discontinued due to alcohol relapse.

Study Details

Locations

Pacific Treatment & Research in Psychedelics — Santa Monica, California, United States

Related Publications

Nature-themed video intervention may improve cardiovascular safety of psilocybin-assisted therapy for alcohol use disorder

Published
Authors
Heinzerling, K. G., Sergi, K., Linton, M., Rich, R., Youssef, B., Bentancourt, I., Bramen, J., Siddarth, P., Schwartzberg, L., Kelly, D. F., Ahmed, S.

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