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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining psilocybin (a psychedelic compound) with therapy can help people reduce alcohol consumption more effectively than therapy with a placebo. Researchers aim to determine if this approach is both effective and safe for participants. The trial includes therapy sessions and capsules containing either psilocybin or a placebo. It seeks individuals diagnosed with moderate to severe Alcohol Use Disorder who wish to cut back or quit drinking. Participants must be generally healthy and free of certain psychiatric disorders and recent hallucinogen use. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin is generally safe for people. Studies have found that when used in therapy for conditions like depression and alcohol use disorder, psilocybin usually does not cause serious side effects.

In several trials, some participants experienced temporary effects such as mood changes or altered perception, but these effects were typically mild and short-lived. Psilocybin has low toxicity, meaning it does not significantly harm the body, even in larger amounts.

When used in a controlled setting, such as a clinical trial with therapy sessions, psilocybin is generally safe for participants. However, not everyone will react the same way, and a monitored environment helps manage any unexpected reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Unlike the standard treatments for alcoholism, which often include medications like naltrexone or acamprosate, psilocybin uses a different approach by incorporating a psychedelic substance. Psilocybin is unique because it targets the brain's serotonin receptors, potentially leading to profound changes in perception, mood, and behavior. Researchers are excited about psilocybin because it might offer long-lasting effects after just a couple of doses, unlike most current treatments, which require ongoing medication. This could mean more sustainable recovery outcomes for individuals with alcohol use disorders.

What evidence suggests that psilocybin therapy might be an effective treatment for alcoholism?

Research has shown that psilocybin, one of the treatments in this trial, may help treat Alcohol Use Disorder (AUD) when combined with therapy. In earlier studies, participants who received psilocybin therapy consumed significantly less alcohol than those given a placebo. Specifically, one study found that psilocybin-assisted treatment helped individuals abstain from alcohol. Overall, psilocybin appears to reduce symptoms of substance use problems, including AUD. This trial will compare psilocybin with a placebo to evaluate its effectiveness in reducing alcohol consumption in people with AUD. ^{1 6 7 8 9}

Who Is on the Research Team?

Hannu Alho, MD

Principal Investigator

Addiktum Oy

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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, 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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947277/

Therapeutic effect of psilocybin in addiction: A systematic ... All four clinical trials indicated a beneficial effect of psilocybin-assisted therapy on SUD symptoms.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02061293?cond=%22Alcohol%20Dependence%22&intr=%22Histamine%20phosphate%22&viewType=Table&rank=1

A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. digitalcommons.onu.edu digitalcommons.onu.edu/cgi/viewcontent.cgi?article=1193&context=paw_review

Psilocybin Utilization in Alcohol Use Disorder The results of the trial concluded that psilocybin produced statistically significant outcomes compared to placebo for patients with AUD, ...

4. preprints.org preprints.org/manuscript/202510.1355/v1/download

Psilocybin in Alcohol Use Disorder Maintains Abstinence ... This review aims to evaluate the results of the most recent clinical trials assessing psilocybin as a treatment for alcohol use disorder.

5. patents.google.com patents.google.com/patent/US20240000814A1/en

Treating alcohol use disorder using psilocybin This multi-site randomized controlled trial evaluated the efficacy of psilocybin-assisted treatment of AUD. Here we report drinking outcomes for the double- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9577917/

Psilocybin-assisted therapy for reducing alcohol intake in ... Psilocybin-assisted therapy will cause a larger reduction in alcohol consumption measured as percentage of heavy drinking days compared with placebo-assisted ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12495261/

Considerations and cautions for the integration ... To date, a growing body of evidence has shown great promise for the use of psilocybin in the treatment of major depressive disorder (MDD),1, 2, 3 alcohol use ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S027858462500003X

Psilocybin as Antidepressant: Clinical & Preclinical Evidence The safety profile is considered favourable, with low toxicity and good tolerance. Several preclinical studies have also been carried out to ...

9. researchgate.net researchgate.net/publication/393979596_Psilocybin_in_alcohol_use_disorder_and_comorbid_depressive_symptoms_Results_from_a_feasibility_randomized_clinical_trial

Psilocybin in alcohol use disorder and comorbid ... In conclusion, our results in the ADE model do not support the hypothesis that microdosing or high doses of psychedelic reduce relapse behavior.