Health TrialsbyHealthPanel

Psilocybin-assisted Therapy for Alcohol Use Disorder

ConditionsAlcohol Use DisorderAlcohol DependenceDepressionAnxiety
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

About this trial

To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderate to severe AUD according to the DSM-5 criteria

A desire to reduce or stop drinking

Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks/day for men; ≥4 for women) in the past week prior to screening

Aged ≥18 years old

Disqualifiers

Any psychotic disorder

Bipolar disorder type 1 or 2

Major depression with psychotic features

Any personality disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi.

  • Niacin

    Drug

    A nutrient in the vitamin B complex that the body needs in small amounts to function and stay healthy. Niacin helps some enzymes work properly and helps skin, nerves, and the digestive tract stay healthy. Niacin is found in many plant and animal products. Niacin will be used at a concentration of 250mg as an active control.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Psilocybin + TherapyExperimental treatment 1 intervention
Group B: Niacin + TherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of Heavy Drinking Days (HDD)

Frequency of HDD as measured by the Timeline Follow Back (TLFB) and validated by Phosphatidylethanol (PEth). HDD are defined as ≥4 drinks/day for women and ≥5 drinks/day for men.

Time frame
52 Weeks

Secondary outcomes

1

Mean alcohol consumption per drinking day

The mean alcohol consumption per drinking day will be gathered reported as the number of standard drinks consumed each day.

Time frame
52 Weeks
2

Absence of any HDD

Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels

Time frame
52 Weeks
3

WHO drinking risk level

The WHO categorizes alcohol consumption into different risk levels based on average daily intake and associated health risks: Abstainer: Rarely or never drinks alcohol. Low-risk drinking: (Men: Up to 2 standard drinks per day, Women: Up to 1 standard drink per day). Moderate-risk drinking: (Men: 3-4 standard drinks per day, Women: 2-3 standard drinks per day). High-risk drinking: (Men: More than 4 standard drinks per day, Women: More than 3 standard drinks per day). Heavy episodic (binge) drinking: 60 grams (5-6 drinks) or more on a single occasion.

Time frame
52 Weeks
4

Dependence Severity

Alcohol Dependence Scale (ADS) is a measure of the severity of the participant's dependence on alcohol. The measure contains 29 items regarding symptoms and occurrences associated with dependence on alcohol. A total score for the measure is yielded by adding across items. Higher scores indicate more severe dependence.

Time frame
52 Weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

University of Sydney

Lead sponsor

Woke Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: