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Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Are 18 to 65 years old, inclusive, at Screening visit.

Disqualifiers

Pregnancy or lactation

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

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

  • Inactive Placebo

    Other intervention

    Two matching placebo capsules administered once orally

  • Supportive therapy sessions

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Oral high-dose of psilocybinExperimental treatment 2 interventions
Group B: Placebo controlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline, Day 2

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
IP Administration (Day 0), Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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