What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like naltrexone, acamprosate, and disulfiram. Naltrexone can cause side effects such as nausea, headache, dizziness, and fatigue. Acamprosate may lead to diarrhea, anxiety, and insomnia. Disulfiram can cause drowsiness, headache, and a metallic taste, and it produces severe reactions if alcohol is consumed. Psilocybin, a serotonin receptor agonist, is being studied for its potential in treating alcohol use disorder. Known side effects of psilocybin include transient anxiety, nausea, and perceptual changes, but it generally has a favorable safety profile when administered in controlled settings.

What prior FDA approvals exist?

FDA-approved treatments for alcoholism include disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, while naltrexone is an opioid receptor antagonist that reduces the rewarding effects of alcohol. Acamprosate helps to stabilize chemical balance in the brain that would otherwise be disrupted by alcohol withdrawal. While these treatments are effective, they differ from psilocybin, which is a serotonin receptor agonist currently being studied for its potential to reduce alcohol consumption through its effects on brain serotonin levels.

What other types of research exist?

Ayahuasca, a psychoactive beverage containing DMT and β-carbolines, has shown potential in preclinical studies for treating alcohol use disorder. It has been found to block ethanol-induced conditioned place preference in mice, reduce anxiogenic responses to ethanol withdrawal, and modulate neuroplastic changes induced by ethanol. Additionally, ayahuasca presents a low-risk acute toxicological profile when administered orally.

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Psilocybin Therapy for Alcoholism

Phase 2

Recruiting

Led By Hannu Alho, MD

Research Sponsored by Clairvoyant Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Summary

This trial is testing whether psilocybin, a substance from certain mushrooms, combined with therapy can help people who drink too much alcohol. Psilocybin has shown promise in reducing heavy drinking days in previous trials for alcohol use disorder. The study will see if this combination works better than therapy alone. Participants will attend therapy sessions and take either psilocybin or another substance to see if their drinking decreases.

Who is the study for?

This trial is for adults with a moderate to severe Alcohol Use Disorder (AUD) who want to cut down or stop drinking. They must be generally healthy, without unstable medical conditions, and have no history of hallucinogen use disorder or significant psychiatric disorders like schizophrenia or bipolar disorder.

What is being tested?

The study tests if psilocybin-assisted psychotherapy can help reduce alcohol consumption more effectively than placebo-assisted therapy. Participants will attend 13 visits, undergo therapy sessions including two where they'll receive either psilocybin or a placebo, and track their daily alcohol intake.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of psilocybin may include nausea, headache, increased heart rate and blood pressure, dizziness, and psychological effects such as altered perception of time and space.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in the number of Heavy Drinking Days

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PsilocybinExperimental Treatment1 Intervention

2 oral doses of 25mg psilocybin capsules

Group II: PlaceboPlacebo Group1 Intervention

2 oral doses of placebo (microcrystalline cellulose) capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~750

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism include medications like naltrexone, acamprosate, disulfiram, and emerging treatments like psilocybin. Naltrexone works by blocking opioid receptors, reducing the rewarding effects of alcohol and decreasing cravings. Acamprosate modulates glutamate neurotransmission, helping to restore the balance of neurotransmitters disrupted by chronic alcohol use. Disulfiram inhibits the enzyme acetaldehyde dehydrogenase, causing unpleasant reactions when alcohol is consumed, thus deterring drinking. Psilocybin, a serotonin receptor agonist, is being studied for its potential to reset neural circuits and reduce alcohol cravings and consumption. These treatments are crucial as they address the neurochemical imbalances and behavioral aspects of alcoholism, offering patients multiple pathways to recovery.

Serotonergic Neuroplasticity in Alcohol Addiction.