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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin Group (Arm 1) | Experimental | receives individual psychotherapy sessions plus a (30 mg) psilocybin session. |
|
| Ketamine Group (Arm 2) | Active Comparator | receives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | 30 mg single dose |
| |
| Ketamine |
| Measure | Description | Time Frame |
|---|---|---|
| Timeline Follow-Back for Alcohol to assess change | Quantifies daily alcohol use | Weekly, over the course of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| T1rho | Measures biological changes in the brain | Twice (before intervention, post intervention): at week 1 and week 16 |
| Resting state fMRI | Measures biological changes in brain resting state global functional connectivity |
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Inclusion 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 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.)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay E Golden, BS | Contact | 319-384-5243 | lindsay-golden@uiowa.edu | |
| Peggy C Nopoulos, MD | Contact | 319-356-1144 | peggy-nopoulos@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peggy C Nopoulos, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52240 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Drug |
0.75 mg/kg weight-based single dose |
|
| Twice (before intervention, post intervention):: at week 1 and week 16 |
| EEG- signal complexity | Measures electrical signal change | Twice (before drug administration and at peak of drug experience) during week 3 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |