Comparing psilocybin and ketamine therapy for alcohol use disorder
Psilocybin-Assisted Vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
PHASE2 · University of Iowa · NCT05421065
This study is testing whether therapy with psilocybin or ketamine can help people with alcohol use disorder reduce their drinking and improve their overall well-being.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | Male |
| Sponsor | University of Iowa (other) |
| Locations | 1 site (Iowa CIty, Iowa) |
| Trial ID | NCT05421065 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to collect preliminary data on the effects of psilocybin-assisted psychotherapy versus ketamine-assisted psychotherapy in patients with alcohol use disorder. It is a double-blind, randomized, active-comparator controlled trial with two arms, where participants will receive either psilocybin or ketamine during individual psychotherapy sessions. The study includes psychiatric evaluations, MRI scans, and follow-up assessments to evaluate the impact of the therapies on alcohol use. Each participant will undergo four psychotherapy sessions over four weeks, with a focus on integrating their experiences.
Who should consider this trial
Good fit: Ideal candidates are English-speaking males aged 25-65 who meet the criteria for moderate or severe alcohol use disorder.
Not a fit: Patients with a history of significant medical conditions, other substance use disorders, or recent use of hallucinogens or ketamine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new therapeutic options for individuals struggling with alcohol use disorder.
How similar studies have performed: While there is emerging interest in the use of psychedelics for treating substance use disorders, this specific comparison of psilocybin and ketamine-assisted psychotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 of 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 as subjects who take psilocybin may experience a worsening and/or persistent psychotic state. Therefore, these subjects are excluded due to an abundance of caution since even a family history may create a vulnerability to psychosis. * 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: * 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.)
Where this trial is running
Iowa CIty, Iowa
- University of Iowa — Iowa CIty, Iowa, United States (RECRUITING)
Study contacts
- Principal investigator: Peggy C Nopoulos, MD — University of Iowa
- Study coordinator: Peggy C Nopoulos, MD
- Email: peggy-nopoulos@uiowa.edu
- Phone: 319-356-1144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, psilocybin, ketamine