Alcohol Use DisorderPhase 2Psi or KetNCT06405607
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
A Phase 2 study testing Psilocybin and Ketamine in people with Alcohol Use Disorder and Alcohol Dependence, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse
- What is being tested?
- Psilocybin and Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52240
Lindsay E Golden, lindsay-golden@uiowa.edu
About this study
Official title: Psilocybin vs Ketamine for Alcohol Use Disorder
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.
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse
- Being tested
- Psilocybin, Ketamine
- Keywords
- psychedelic, psilocybin, ketamine
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
30 mg single dose
KetamineDrug
0.75 mg/kg weight-based single dose
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Group (Arm 1) | Experimental | receives individual psychotherapy sessions plus a (30 mg) psilocybin session. Receives: Drug: Psilocybin |
| Ketamine Group (Arm 2) | Active comparator | receives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-Back for Alcohol to assess change
Quantifies daily alcohol use
Measured: Weekly, over the course of 16 weeks
Secondary outcomes (3)
T1rho
Measures biological changes in the brain
Measured: Twice (before intervention, post intervention): at week 1 and week 16
Resting state fMRI
Measures biological changes in brain resting state global functional connectivity
Measured: Twice (before intervention, post intervention):: at week 1 and week 16
EEG- signal complexity
Measures electrical signal change
Measured: Twice (before drug administration and at peak of drug experience) during week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start12 Jun 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peggy C Nopoulos, University of Iowa
- Investigators
- Peggy C Nopoulos, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405607
- Sponsor's protocol ID
- 202404714
- Acronym
- Psi or Ket
- Status last verified
- Nov 2025
- First submitted
- 2 May 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin vs Ketamine for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06405607
- Acronym / sponsor ID
- Psi or Ket / 202404714
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse
- Keywords
- psychedelic, psilocybin, ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Group (Arm 1) | Experimental | Drug: Psilocybinreceives individual psychotherapy sessions plus a (30 mg) psilocybin session. |
| Ketamine Group (Arm 2) | Active comparator | Drug: Ketaminereceives individual psychotherapy sessions plus a (0.75 mg/kg) ketamine session |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin30 mg single dose | Drug | Psilocybin Group (Arm 1) |
| Ketamine0.75 mg/kg weight-based single dose | Drug | Ketamine Group (Arm 2) |
Primary outcome
Timeline Follow-Back for Alcohol to assess change
Time frame: Weekly, over the course of 16 weeks
Quantifies daily alcohol use
3 secondary outcomes
T1rho
Time frame: Twice (before intervention, post intervention): at week 1 and week 16
Resting state fMRI
Time frame: Twice (before intervention, post intervention):: at week 1 and week 16
EEG- signal complexity
Time frame: Twice (before drug administration and at peak of drug experience) during week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peggy C Nopoulos, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin and Ketamine in people with Alcohol Use Disorder and Alcohol Dependence, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay E Golden, BS (319-384-5243, lindsay-golden@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Follow-Back for Alcohol to assess change (time frame: Weekly, over the course of 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.