Clinical trial NCT06405607: Psilocybin Vs Ketamine for Alcohol Use Disorder
Official title: Psilocybin Vs Ketamine for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Alcohol Dependence
Alcohol Abuse
Keywords: psychedelic
psilocybin
ketamine
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.


Eligibility criteria: Inclusion criteria:

* Weight between 50kg and 150kg
* No known allergies to rescue medication
* For people capable of becoming pregnant, not pregnant and using contraception
* Not currently breastfeeding
* 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 12 months
* 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 other than AUD over the past 12 months
* If taking a GLP-1 agonist, stable dosage for past 3 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 disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 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), or pregnancy.

MRI contraindication (pacemaker, etc.)

Primary outcomes:
measure: Timeline Follow-Back for Alcohol to assess change
timeFrame: Weekly, over the course of 16 weeks
Secondary outcomes:
measure: T1rho
timeFrame: Twice (before intervention, post intervention): at week 1 and week 16
measure: Resting state fMRI
timeFrame: Twice (before intervention, post intervention):: at week 1 and week 16
measure: EEG- signal complexity
timeFrame: Twice (before drug administration and at peak of drug experience) during week 3
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Peggy C Nopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: