Clinical TrialAlcohol Use Disorder (AUD)PsilocybinKetamineActive not recruiting

Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Randomized, open-label, active-comparator controlled trial (n=20) comparing psilocybin-assisted psychotherapy (25 mg oral) vs ketamine-assisted psychotherapy (200 mg oral) in males with moderate or severe alcohol use disorder.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

Parallel-group randomised trial comparing a single 25 mg oral psilocybin administration plus integrative psychotherapy to a single 200 mg oral ketamine administration plus integrative psychotherapy; each participant receives four psychotherapy sessions (two preparatory, one dosing, two integration).

Assessments include baseline and post-treatment MRI scans, weekly follow-up for four weeks, and final assessment at week 8; ketamine participants are offered an open-label psilocybin session with two integration visits and additional follow-up in an extension.

Primary outcomes focus on preliminary efficacy signals on alcohol use; safety monitoring includes drug screens, vitals, adverse events and medical/psychiatric assessments.

Study Protocol

Preparation

2 sessions

Dosing

1 sessions

Integration

2 sessions

Therapeutic Protocol

other

Study Arms & Interventions

Psilocybin

experimental

25 mg oral psilocybin with integrative psychotherapy (4 sessions).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single 25 mg oral dose paired with psychotherapy sessions.

Ketamine

active comparator

200 mg oral ketamine with integrative psychotherapy (4 sessions).

Interventions

  • Ketamine200 mg
    via Oral• single dose• 1 doses total

    Single 200 mg oral dose paired with psychotherapy sessions; ketamine arm offered open-label psilocybin and integration in extension.

Participants

Ages
25 – 65
Sexes
male

Inclusion Criteria

  • Inclusion Criteria:
  • 25-65 years old
  • Male
  • English fluency
  • Meets criteria for DSM-V moderate or severe AUD
  • Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days
  • No history of a cerebrovascular accident, asthma, or significant alcohol withdrawal history
  • No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes
  • No current substance use disorder other than AUD
  • Negative drug screen (other than THC) on drug administration day
  • No prescription medications classified as UGT1A9 inhibitors, UGT1A10 inhibitors, aldehyde or alcohol dehydrogenase inhibitors
  • At least a high-school level of education or equivalent (e.g. GED)
  • Lived at current residence for at least 3 months
  • Family member/friend for pick-up, overnight post-drug session monitoring
  • No hallucinogen or ketamine use in past 1 year
  • No self-reported, personal, or familial history of specific psychotic disorders/episodes
  • No serious traumatic brain injury (TBI) in the past 2 years
  • No known allergies to rescue medication (diazepam)
  • Weight between 110 and 330 lbs

Exclusion Criteria

  • Exclusion Criteria:
  • Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants, or benzodiazepines)
  • Psychiatric assessment that yields: 1) history of severe suicide attempt, 2) current suicidality, 3) first degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use including cocaine, psychostimulant, or opioid use disorder within past 12 months and/or any use within past 30 days, 5) history of co-occurring psychotic episode/diagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation
  • Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation > .045), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function)
  • MRI contraindication (pacemaker, etc.)

Study Details

Locations

University of Iowa — Iowa City, Iowa, United States

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