Psilocybin Therapy for Alcoholism

Recruiting at 13 trial locations

Overseen By Teresa Yan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Clairvoyant Therapeutics

Disqualifiers: Schizophrenia, Bipolar, OCD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

128 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug psilocybin for treating alcoholism?

Preliminary studies have shown that psilocybin, the active ingredient in magic mushrooms, may help treat alcohol addiction and other conditions like depression and obsessive-compulsive disorder. These studies suggest that psilocybin can lead to significant improvements even in patients who haven't responded to other treatments. ^{1 2 3 4 5}

Is psilocybin generally safe for humans?

Psilocybin has been studied in healthy adults with escalating doses, showing a safety profile that is generally well-tolerated. However, it can cause rapid effects on the central nervous system, such as hallucinations and physical symptoms like ataxia (loss of control of body movements) and hyperkinesis (increased movement). ^{1 3 6 7 8}

How is psilocybin therapy different from other treatments for alcoholism?

Psilocybin therapy is unique because it involves the use of a psychedelic compound found in certain mushrooms, which can lead to significant changes in perception and consciousness. Unlike traditional treatments, psilocybin is administered in one or two supervised sessions and has shown promise in increasing abstinence from alcohol after its administration, suggesting a novel approach to treating alcohol dependence. ^{2 3 4 5 9}

Research Team

Hannu Alho, MD

Principal Investigator

Addiktum Oy

Eligibility Criteria

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.

Inclusion Criteria

I want to cut down or quit drinking alcohol.

Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology

Moderate to severe diagnosis of AUD as measured by DSM-5 criteria using Structured Clinical Interview for DSM-5 by the investigator

Exclusion Criteria

History of hallucinogen use disorder, any use in the past 1 year, or more than 25 lifetime uses

I was diagnosed with a severe mood or anxiety disorder or an eating disorder in the last year.

I or someone in my family has been diagnosed with schizophrenia, bipolar disorder, OCD, or experienced a psychotic episode.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin or placebo during therapy sessions to reduce alcohol consumption

8 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Psilocybin

Trial Overview 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.

Participant Groups

Group I: Psilocybin Experimental Treatment 1 Intervention

2 oral doses of 25mg psilocybin capsules

Group II: Placebo Placebo Group 1 Intervention

2 oral doses of placebo (microcrystalline cellulose) capsules

Who Is Running the Clinical Trial?

Clairvoyant Therapeutics

Lead Sponsor

Trials

1

Recruited

130+

Optimapharm

Collaborator

Trials

1

Recruited

130+

Optimapharm

Industry Sponsor

Trials

6

Recruited

840+

Findings from Research

A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.

Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. Hirschfeld, T., Schmidt, TT.[2022]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

Psilocybin, a compound found in 'magic mushrooms', has shown potential in recent studies for treating various mental health conditions, including obsessive-compulsive disorder, alcohol and tobacco addiction, and major depressive disorder, particularly in terminally ill cancer patients.

Despite its classification as a Schedule I drug in 1970, which halted much research, there is a renewed interest in psilocybin's therapeutic effects, highlighting its importance in both historical and contemporary neuroscience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DARK Classics in Chemical Neuroscience: Psilocybin. Geiger, HA., Wurst, MG., Daniels, RN.[2019]

In a phase 2 trial with patients suffering from major depressive disorder, psilocybin therapy (PT) led to significant improvements in personality traits associated with mental health, such as decreased neuroticism and increased openness, after 6 weeks.

Both psilocybin and escitalopram treatments resulted in positive changes in personality, but no significant differences were found between the two treatments, suggesting that both may be effective in improving mental health through similar mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personality change in a trial of psilocybin therapy v. escitalopram treatment for depression. Weiss, B., Ginige, I., Shannon, L., et al.[2023]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

In a proof-of-concept study involving 10 alcohol-dependent participants, psilocybin administration led to a significant increase in abstinence rates after treatment, with effects maintained for up to 36 weeks.

Participants experienced no significant adverse events, suggesting that psilocybin is safe for use in this context, and the intensity of the psilocybin effects predicted positive changes in drinking behavior and cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. Bogenschutz, MP., Forcehimes, AA., Pommy, JA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

DARK Classics in Chemical Neuroscience: Psilocybin. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Personality change in a trial of psilocybin therapy v. escitalopram treatment for depression. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. [2022]