Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder
Conditions
Keywords
psychedelic, psilocybin, ketamine
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.
Interventions
DRUGPsilocybin
30 mg single dose
DRUGKetamine
0.75 mg/kg weight-based single dose
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timeline Follow-Back for Alcohol to assess change | Weekly, over the course of 16 weeks | Quantifies daily alcohol use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1rho | Twice (before intervention, post intervention): at week 1 and week 16 | Measures biological changes in the brain |
| Resting state fMRI | Twice (before intervention, post intervention):: at week 1 and week 16 | Measures biological changes in brain resting state global functional connectivity |
| EEG- signal complexity | Twice (before drug administration and at peak of drug experience) during week 3 | Measures electrical signal change |
Countries
United States
Contacts
Primary ContactLindsay E Golden, BS
Backup ContactPeggy C Nopoulos, MD
Outcome results
None listed