Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-07-21

Brief Summary

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The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD.

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Detailed Description

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The investigators will evaluate the feasibility and safety of administering psilocybin to 10 patients diagnosed with AUD. Following informed consent, patients will be screened for eligibility as per in- and exclusion criteria and baseline values will be recorded as per outcome measures. All patients will receive a single administration of 25 mg of psilocybin. As per safety guidelines patients will be monitored the entire dosing session by study staff familiar with the psychedelic effects of psilocybin. In addition, the patients will meet before and after the dosing session with a psychologist connected to the study for preparation and post-session debriefing, respectively. During dosing session, the investigators will collect blood plasma psilocin levels in order to establish pharmacokinetics and an estimated brain 5-HT2AR occupancy. When the effects of psilocybin subside, the investigators will ask the patients to fill out questionnaires encapsulating the psychedelic experience. One week after drug administration the patients are required to meet for an end-of-study assessment of outcome measures including adverse events.

Conditions

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Alcohol Use Disorder (AUD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin

10 patients will receive a single administration of psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

A single administration of PEX010 (psilocybin 25 mg, opaque capsule for oral ingestion). PEX010 contains psilocybin (25 mg) naturally extracted from Psilocybe cubensis mushroom fruiting bodies, manufactured under current Good Manufacturing Practices (cGMP)

Interventions

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Psilocybin

A single administration of PEX010 (psilocybin 25 mg, opaque capsule for oral ingestion). PEX010 contains psilocybin (25 mg) naturally extracted from Psilocybe cubensis mushroom fruiting bodies, manufactured under current Good Manufacturing Practices (cGMP)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age of 20-70 years (both included).
2. Body weight of 60-95 kg (both included).
3. Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
4. Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
5. ≥ 5 heavy drinking days.

Exclusion Criteria

1. Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
2. History of delirium tremens or alcohol withdrawal seizures.
3. History of suicide attempt or present suicidal ideation.
4. Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
5. Present or former severe neurological disease including head trauma with loss of consciousness \> 30 min.
6. Impaired hepatic function (liver transaminases \> 3 times upper normal limit).
7. Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
8. Abnormal electrocardiogram
9. Impaired renal function (eGFR \< 50 ml/min).
10. Uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg).
11. Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
12. Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
13. Any other active substance use defined as a Drug Use Disorder Identification Test score \> 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
14. Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
15. Hypersensitivity to the active substance or to any of the excipients.
16. Unable to speak and/or understand Danish.
17. Any condition that the investigator feels would interfere with trial participation.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No