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Alcohol Use DisorderPhase 2NCT06349083

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

A Phase 2 study testing Psilocybin and Supportive therapy sessions in people with Alcohol Use Disorder, run by NYU Langone Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Psilocybin and Supportive therapy sessions
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to May 2030
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are able to provide voluntary informed consent
  • Have a breath alcohol concentration (BrAC) ≤ 0.01% at screening, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening period.
  • Are able to read, speak, and understand English, as documented during the informed consent process.
  • Non-English speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments.
  • Are 18 to 65 years old, inclusive, at Screening visit.
  • Have DSM-5 diagnosis of moderate or severe AUD (using MINI)
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  • Eligible participants must either (a) not currently receiving treatment for alcohol use disorder (AUD), or (b) have been in continuous treatment for AUD for at least 3 months and plan to continue. (Any medications used to treat AUD would need to be discontinued no less than 5 half lives or 14 days (whichever is greater) prior to the IP administration session. Patients who who are completing detoxification from alcohol and do not have plans for follow-up treatment would be eligible to participate in the study after completion of the detoxification program).
  • Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments.
  • Have least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to admission to the screening visit.
  • Agree to refrain from alcohol use as well as any non-prescribed psychotropic substance or illicit drug use for at least 24 hours prior to investigational product (IP) administration and before each fMRI assessment visit, with the exceptions of nicotine and caffeine. Regarding nicotine, they must agree not to use nicotine for at least 1 hour before and 6 hours following IP administration, and for at least 1 hour before fMRI scans. Regarding caffeine, they must agree to consume approximately their usual amount of caffeine on the morning of Day 0 (prior to IP administration).
  • Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.
  • Are able to swallow capsules.
  • If able to become pregnant, have a negative serum pregnancy test at screening.
  • If able to become pregnant or produce viable sperm (male or female), are willing to use approved contraception for duration of the trial
  • Able to provide at least 2 locators.
  • Participants must be able to commit to being sober at the time all treatment sessions and the two fMRI sessions, and to stay sober from the time of the drug administration until the second fMRI session.

Who cannot join

  • Pregnancy or lactation
  • Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests:
  • Seizure disorder
  • Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN); 2) ALT or AST > 3 × ULN with concomitant total bilirubin > 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia.
  • Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of cerebrovascular accident or transient ischemic attack.
  • Uncontrolled hypertension with systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg. (Note: participants who otherwise meet all eligibility criteria during the screening visit will have 3 opportunities to produce 1 blood pressure reading ≤ 140/90 mmHg (each reading will be collected at least 15 minutes apart). If blood pressure at Screening is consistently elevated (> 140/90 mmHg across all 3 attempts), participants may be referred to their medical provider for management of hypertension. Participants may continue study participation if they are able to provide documentation of adequate control (BP > 140/90 mmHg) prior to the IP administration session.)
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  • Resting heart rate > 100 bpm (Note: participants will have an opportunity to return once within the 30 day screening window to make 3 additional attempts at a resting heart rate ≤ 100 bpm.).
  • Serious ECG abnormalities present on the ECG obtained at the screening visit (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate [QTc] prolongation (QTc > 0.450 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia.
  • Hyperthyroidism
  • Insulin-dependent diabetes
  • Any other medical condition which precludes safe participation in the study in the medical opinion of the Investigator. (Note: medical history will be updated on Day 0. Those not meeting the criterion will not be randomized but may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator.)
  • Have any of the following DSM-5 psychiatric disorders, as determined by the MINI and Psychiatric History at the Screening Visit: (Note: psychiatric history will be re-evaluated on Day 0, but the MINI will not be re-administered on Day 0)
  • Lifetime history of schizophrenia spectrum or other psychotic disorder (including substance or medication-induced psychosis or psychosis due to a co-occurring medical condition).
  • Current alcohol withdrawal (CIWA-Ar score >7)
  • History of mania
  • Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS) (past week severity score >3) at the Screening visit, confirmed by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day 0, and on Day 0 prior to randomization. Participants will be withdrawn if actively suicidal, and appropriate follow-up will be arranged.
  • Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day 0, and on Day 0 prior to randomization. Participants will be withdrawn if actively suicidal, and appropriate follow-up will be arranged.)
  • Have a family history (first degree relatives) of schizophrenia, schizoaffective disorder, or bipolar disorder type 1.
  • Have a history of hallucinogen use disorder.
  • Have a history of hallucinogen persisting perceptual disorder (HPPD).
  • Have any use of classic psychedelics in the past 1 year.
  • Have > 25 lifetime uses of classic psychedelics.
  • Incarcerated or have pending legal action that could prevent participation in study activities.
  • Are court-mandated to complete treatment or are a prisoner.
  • Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements. (A detailed list of exclusionary medications is found in Section 6.5 of the protocol). Current SSRI use is allowed only if the dose has been stable for at least one month at the time of Screening visit. Prohibited medications and supplements must have been stopped for at least 5 elimination half-lives or 14 days, whichever is longer, prior to Day 0 (Note: Psychiatric medications will not be discontinued or changed in order to allow study participation unless such change does not cause any increase in risk to the study participant, in the judgement of the study physician and the prescribing provider. For example, a change in a medication for sleep might be appropriate if a non-exclusionary alternative is available. Any such study-related changes in medication will be documented in a progress note which will include explanation for why the change does not increase overall clinical risk and documentation of the prescribers concurrence with the treatment plan.)
  • Note that any medication prescribed to the participant for AUD is exclusionary, including FDA-approved medications as well those prescribed off-label, such as topiramate, ondansetron, gabapentin, and varenicline.
  • Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study.
  • Have an allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms if necessary during or immediately after the IP Administration Session, using the adjunctive medications used in this study to treat these symptoms (i.e., unable to take captopril and unable to take clonidine; unable to take diazepam; or unable to take olanzapine).
  • Have any other medical, psychiatric, or psychosocial disorder, symptom, condition, or situation that is likely to interfere with the establishment of rapport, adherence to study requirements, or safe administration of psilocybin or fMRI scanning, based on the judgement of the Investigator.
  • Inability to safely complete fMRI sessions (MRI screening form), including presence of metallic implants or devices that contraindicate MRI or claustrophobia.
  • Any history of severe traumatic brain injury (assessed using OSU TBI-ID modified). (Note: If current (past 12 months) mild/moderate TBI and CSI score >/=12 (for either lifetime month or current month), the PI will determine eligibility.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Bogenschutz, MD contact

646-501-4026

Michael.bogenschutz@nyulangone.org

Quincey Pyatt contact

631-386-3455

quincey.pyatt@nyulangone.org

United States1 site, 1 recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

Other trials in United States

About this study

Official title: Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

Being tested
Psilocybin, Inactive Placebo, Supportive therapy sessions
Keywords
psilocybin, AUD
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    One 25 mg capsule and one 5 mg capsule (30 mg total) administered once orally

  • Inactive PlaceboOther

    Two matching placebo capsules administered once orally

  • Supportive therapy sessionsBehavioural

    Participants will receive four supportive therapy sessions of manual-based treatment from two Center for Psychedelic Medicine (CPM) clinicians. The lead clinician will be a licensed physician, clinical psychologist, or nurse practitioner who will be primarily responsible for the content of the intervention. The second therapist will have at least a master's degree or be pursuing a master's or doctoral degree in a related clinical field.

Study groups in NCT06349083
Study groupRoleWhat they receive
Oral high-dose of psilocybinExperimentalParticipants will receive a single IP administration session of psilocybin (30 mg total) and four supportive therapy sessions.
Receives: Drug: Psilocybin; Behavioral: Supportive therapy sessions
Placebo controlPlacebo comparatorParticipants will receive a single IP administration session of matching placebo capsules and four supportive therapy sessions.
Receives: Other: Inactive Placebo; Behavioral: Supportive therapy sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC)

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  2. Percent change in the alcohol cue-induced BOLD signal change in the caudate

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  3. Percent change in alcohol cue-induced BOLD signal change in the ventromedial PFC (vmPFC)

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  4. Percent change in alcohol cue-induced BOLD signal change in the inferior frontal gyrus (IFG)

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  5. Percent change in alcohol cue-induced BOLD signal change in the insula

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  6. Percent change in negative affective cue-induced BOLD signal change in the dorsomedial PFC (dmPFC)

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the alcohol cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  7. Percent change in negative affective cue-induced BOLD signal change in the supramarginal gyrus

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the negative affective cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  8. Percent change in negative affective cue-induced BOLD signal change in the amygdala

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the negative affective cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  9. Percent change in negative affective cue-induced BOLD signal change in the insula

    Percentage change in the BOLD signal is the difference in fMRI signal between the baseline condition (B) and the negative affective cue-induced task condition (T); percent signal change = (T-B)/B×100%. A positive value of the percentage change in BOLD signal indicates up-regulation of BOLD signal.

    Measured: Baseline, Day 2

  10. Percent change in alcohol cue-induced functional connectivity in prespecified regions of interest (ROI)

    ROI include the ventral striatum, lateral PFC (dlPFC and IFG), and caudate with target clusters in the PFC, ACC, and sensorimotor cortex (S1 and M1).

    Measured: Baseline, Day 2

  11. Percent change in negative affective cue-induced functional connectivity in prespecified regions of interest (ROI)

    ROI include the ventral striatal and amygdala with target clusters in temporal and occipital regions relative to placebo.

    Measured: Baseline, Week 4

  12. Percent change in the frequency of failed response inhibition

    A Go/NoGo task will be used as an objective measure of response inhibition. This task includes alcohol, non-alcohol, and neutral stimuli. The Go/No-go task requires participants to respond by pressing a button when they see a "go" signal, and not respond when they see the "no-go" signal. The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials and the frequency of their failed responses.

    Measured: Baseline, Week 4

  13. Change in discounting rate (log(k))

    The discounting rate is derived from the Delay Discounting Task. Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. The task includes 80 items requiring a choice between a delayed reward of $100 and smaller immediate rewards (ranging from $10 to $99, at delays ranging from one to 365 days. Discounting rates will be measured and pre-post differences will be assessed. Higher k values indicate higher impulsive decision-making.

    Measured: Baseline, Week 4

  14. Change in participant-level reference points

    A Foraging Task will be used as an objective measure of cognitive flexibility. The task involves making "stay" or "go" decisions to harvest apples from stylized "trees" that have hidden initial rewards. Within each block, trees have a mean initial reward rate. Subjects decide to either harvest the tree ("stay") or search for a new one ("go"), incurring an S second delay penalty for searching. Harvesting reveals the reward, which depletes by a fixed amount, plus a small error term. After a 1-second inter-trial interval, the tree reappears for another "stay" or "go" choice. Rewards on each sequential trial are computed. Rewards are computed dynamically, with optimal strategies varying based on the delay penalty. The optimal reference point is calculated using the marginal value theorem, while the empirical reference point is the participant's cutoff for searching.

    Measured: IP Administration (Day 0), Week 24

  15. Percentage of no heavy drinking days

    Outcome will be measured using the Timeline Followback (TLFB) interview-based assessment. The TLFB derives subjects' retrospective daily estimates of alcohol consumption patterns. Using a calendar as a visual aid, special events, and other memory cues, subjects are guided through the process of recalling and reporting daily drinking estimates.

    Measured: Baseline, Week 24

  16. Change in phosphatidyl ethanol (PEth) blood levels

    Measured: Baseline, Week 12

  17. Change in carbohydrate-deficient transferrin (CDT) blood levels

    Measured: Baseline, Week 12

  18. Change in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score

    DrInC-2R is a validated self-report questionnaire consisted of 50 questions to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal as well as frequency of these consequences (answers given on frequency scale grade from 0-3: 0 - never, 1 - once or a few times, 2 - once or twice a week 3 - daily or almost daily). Higher scores indicate greater levels of alcohol-related problems.

    Measured: Baseline, Week 24

  19. Change in PSQI global score

    Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI) . The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations. The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction.

    Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with 0-4 indicating "good" sleep and 5-21 indicating "poor" sleep.

    Measured: Baseline, Week 24

  20. Change in patient's self-assessed health-related quality of life (by the SF-36 Questionnaire)

    The Short Form Health Survey (SF-36) is a validated 36 item self-report Quality of Life Questionnaire that measures eight multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability

    Measured: Baseline, Week 24

  21. Change in Alcohol craving score

    The alcohol cravings score will be assessed using the Penn Alcohol Craving Scale (PACS). The PACS consists of 5 questions with sub-scales ranging from 0 (never) to 6 (nearly all of the time). Scores greater than 20 were considered to meet diagnostic criteria for craving for a diagnosis of Alcohol Use Disorder.

    Measured: Baseline, Week 24

  22. Change in negative affect score

    Negative affect will be assessed using the negative affect scale of the Positive and Negative Affect Schedule (PANAS) which is a 10-item measure of negative emotions on a scale of 1 ("very slightly or not at all) to 5 ("extremely"). Total scores can range from 10 - 50, with higher scores representing higher levels of NA and reflect a dimension of general distress summarizing a variety of negative states such as anger, guilt, or anxiety.

    Measured: Baseline, Week 24

  23. Change in impulsivity score (Barratt impulsivity scale by the subscales and by the total score)

    Impulsivity will be assessed using the Barratt impulsivity scale (BIS-11), a validated self-report questionnaire composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4. Total score is assessed. The total scores can range from 30 to 120. The higher total score corresponds to the more impulsive behavior

    Measured: Baseline, Week 24

Secondary outcomes (7)

  1. Average number of drinks per day

    Outcome will be measured using the Timeline Followback (TLFB) interview-based assessment. The TLFB derives subjects' retrospective daily estimates of alcohol consumption patterns. Using a calendar as a visual aid, special events, and other memory cues, subjects are guided through the process of recalling and reporting daily drinking estimates.

    Measured: IP Administration (Day 0), Week 24

  2. Percentage of abstinent days

    Outcome will be measured using the Timeline Followback (TLFB) interview-based assessment. The TLFB derives subjects' retrospective daily estimates of alcohol consumption patterns. Using a calendar as a visual aid, special events, and other memory cues, subjects are guided through the process of recalling and reporting daily drinking estimates.

    Measured: IP Administration (Day 0), Week 24

  3. Time to First Drinking Day

    Outcome will be measured using the Timeline Followback (TLFB) interview-based assessment. The TLFB derives subjects' retrospective daily estimates of alcohol consumption patterns. Using a calendar as a visual aid, special events, and other memory cues, subjects are guided through the process of recalling and reporting daily drinking estimates.

    Measured: IP Administration (Day 0), Week 24

  4. Time to First Heavy Drinking Day

    Outcome will be measured using the Timeline Followback (TLFB) interview-based assessment. The TLFB derives subjects' retrospective daily estimates of alcohol consumption patterns. Using a calendar as a visual aid, special events, and other memory cues, subjects are guided through the process of recalling and reporting daily drinking estimates.

    Measured: IP Administration (Day 0), Week 24

  5. Change in World Health Organization (WHO) Risk drinking levels

    Outcome will be measured using the Timeline Followback (TLFB) interview-based assessment. The TLFB derives subjects' retrospective daily estimates of alcohol consumption patterns. Using a calendar as a visual aid, special events, and other memory cues, subjects are guided through the process of recalling and reporting daily drinking estimates. These daily drinking estimates will then be used to categorize participants' risk drinking levels based on WHO criteria, which are based on grams of pure ethanol consumed per day.

    Measured: Baseline, Week 24

  6. Probability of Having No Drinking Days

    Probability of having no drinking days from the day of IP administration to the Week 24 follow-up will be calculated using a likely responder analysis. Candidate predictors will include fMRI-derived neural metrics (activation and functional connectivity), clinical features, neuropsychological measures, self-report questionnaires, and outcome expectancies. The LR approach uses a prognostic score, a model of the outcome as a function of pre-treatment variables within the treatment group, to predict each participant's potential response under the treatment.

    Measured: IP Administration (Day 0), Week 24

  7. Probability of Having No Heavy Drinking Days

    Probability of having no heavy drinking days from the day of IP administration to the Week 24 follow-up will be calculated using a likely responder analysis. Candidate predictors will include fMRI-derived neural metrics (activation and functional connectivity), clinical features, neuropsychological measures, self-report questionnaires, and outcome expectancies. The LR approach uses a prognostic score, a model of the outcome as a function of pre-treatment variables within the treatment group, to predict each participant's potential response under the treatment.

    Measured: IP Administration (Day 0), Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionMay 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

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, Care provider
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06349083
Sponsor's protocol ID
23-01227
Other IDs
5R01AA031417-02
Status last verified
Aug 2026
First submitted
1 Apr 2024
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon request and approval by the NIH Data Access Committee immediately following article publication or as required by a condition of awards and agreements supporting the research. The NIH will provide access to scientific investigators for research purposes. Investigators requesting shared data must be affiliated with an NIH-recognized research institution (in the NIH's eRA Commons) that maintains an active FWA, and complete and submit a Data Use Certification approved by an authorized institutional business official with signature authority. Once approved, researchers will be granted access to the entire collection of shared data in the NDA research clusters requested. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin and Supportive therapy sessions in people with Alcohol Use Disorder, run by NYU Langone Health 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 31 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 2 Sep 2026. 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. Some participants in this study may receive a placebo. 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 Michael Bogenschutz, MD (646-501-4026, Michael.bogenschutz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in the alcohol cue-induced Blood-oxygen-level dependent (BOLD) signal in the lateral prefrontal cortex (PFC) (time frame: Baseline, Day 2). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06349083.

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 2 Sep 2026.

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