Psilocybin vs Ketamine for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— Psi vs Ket  

Official title:

Psilocybin vs Ketamine for Alcohol Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405607
• Other study ID #: 202404714
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: University of Iowa
• Contact: Lindsay E Golden, BS
• Phone: 319-384-5243
• Email: lindsay-golden[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of oral psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of intramuscular ketamine.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

Inclusion criteria:

• Male

• Weight between 50kg and 150kg

• No known allergies to rescue medication

• Meets criteria for DSM-V moderate to severe AUD.

• Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.

• Not currently participating in formal treatment for AUD.

• No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history

• No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease

• No hallucinogen or ketamine use in past 3 years

• No self-reported, personal, or familial history of specific psychotic disorders/episodes.

• No serious traumatic brain injury (TBI) in the past 2 years

• No substance use disorder over the past 12 months

• Family member/friend for pick-up, overnight post-drug session monitoring.

• No MRI contraindications

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 that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and/or serious personality disorders amongst other conditions.

Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc > .045]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function).

MRI contraindication (pacemaker, etc.)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Psilocybin
30 mg single dose
• Ketamine
0.75 mg/kg weight-based single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Follow-Back for Alcohol to assess change	Quantifies daily alcohol use	Weekly, over the course of 16 weeks
Secondary	T1rho	Measures biological changes in the brain	Twice (before intervention, post intervention): at week 1 and week 16
Secondary	Resting state fMRI	Measures biological changes in brain resting state global functional connectivity	Twice (before intervention, post intervention):: at week 1 and week 16
Secondary	EEG- signal complexity	Measures electrical signal change	Twice (before drug administration and at peak of drug experience) during week 3