Psilocybin-Assisted Psychotherapy for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether psilocybin, a substance found in certain mushrooms, can improve outcomes for people with severe alcohol use disorder when combined with psychotherapy. Participants will receive either a low or full dose of psilocybin in a controlled setting, alongside therapy sessions. The trial aims to determine if this approach is safe and effective in reducing alcohol use. Ideal candidates have completed detox within the last 90 days and have someone to support them after the psilocybin sessions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, especially those with serotonergic activity, antipsychotics, mood stabilizers, or specific enzyme inhibitors. However, if you're on SSRIs or SNRIs, you can continue them if you've been on a stable dose for at least 30 days before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research suggests that therapy using psilocybin, a compound found in certain mushrooms, might help treat alcohol use disorders. One study showed that participants receiving psilocybin therapy had fewer days of heavy drinking compared to those receiving another treatment, specifically 9.7% heavy drinking days versus 23.6% for the other group.
While psilocybin shows promise, safety remains important. A review of 16 studies found that psilocybin was generally well-tolerated, with most participants not experiencing serious side effects. However, some unknowns remain, especially when psilocybin is combined with alcohol. Participation in a controlled clinical setting, where experts can monitor the treatment, is crucial to ensure safety.12345Why are researchers excited about this trial's treatment for alcoholism?
Researchers are excited about psilocybin-assisted psychotherapy for alcoholism because it taps into the potential of psilocybin, a psychedelic compound found in certain mushrooms, which offers a unique approach compared to traditional treatments like disulfiram, naltrexone, or acamprosate. Unlike these medications that primarily manage cravings or deter alcohol consumption, psilocybin may help individuals gain new psychological insights and enhance emotional processing through its profound effects on consciousness. This treatment is administered in a controlled environment with supportive psychotherapy, which could lead to more sustainable changes in behavior and mindset regarding alcohol use. This novel mechanism of action and the potential for rapid transformation in attitudes towards alcohol make it a promising area of exploration for effectively treating alcoholism.
What evidence suggests that this trial's treatments could be effective for alcoholism?
Research has shown that psilocybin, when combined with therapy, can significantly reduce heavy drinking days for individuals with alcohol use disorder. In this trial, participants will receive either a low dose or a full dose of psilocybin, both paired with a standardized psychotherapy protocol. Studies have found that psilocybin-assisted therapy results in a significant decrease in alcohol use compared to those who did not receive psilocybin. This therapy may help reduce cravings and other factors that lead to drinking. Additionally, psilocybin-assisted therapy has been linked to improved emotional well-being, which can aid in recovery. Overall, early findings suggest a promising role for psilocybin in helping individuals reduce their alcohol use.26789
Who Is on the Research Team?
Joji Suzuki, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
Adults aged 18-65 with severe alcohol use disorder who've completed detox within the last 90 days can join. They must speak English, attend all sessions, have a contact person and someone to stay overnight post-sessions. Excluded are those with certain heart issues, psychiatric conditions, recent substance abuse or high suicide risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two psilocybin dosing sessions spaced four weeks apart, with psychotherapy support before, during, and after dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments up to 48 weeks after the second dosing session
Neuroimaging
Participants complete fMRI scans to evaluate neural response to alcohol-related cues
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The trial is testing if psilocybin-assisted psychotherapy can help adults with severe alcoholism. Participants will get structured therapy and either a full dose (30mg/40mg) or low dose (10mg/15mg) of psilocybin in two sessions, decided randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm receive psilocybin in capsule form at a dose of 30 mg during the first dosing session, with the option to increase to 40 mg at the second session. Doses are administered orally under direct supervision in a controlled clinical setting and paired with a standardized psychotherapy protocol, including preparatory and integration sessions. All participants complete two dosing sessions spaced four weeks apart and receive ongoing support from a peer recovery coach and optional outpatient addiction treatment.
Participants randomized to this arm receive psilocybin in capsule form at a dose of 10 mg during the first dosing session, with the option to increase to 15 mg at the second session. Doses are administered orally under direct supervision in a controlled clinical setting and paired with the same standardized psychotherapy protocol used in the high-dose arm. Participants complete two dosing sessions four weeks apart and receive ongoing support from a peer recovery coach and optional outpatient addiction treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Citations
Percentage of Heavy Drinking Days Following Psilocybin ...
Conclusions and Relevance Psilocybin administered in combination with psychotherapy produced robust decreases in percentage of heavy drinking ...
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 ...
Psilocybin-assisted therapy for relapse prevention in ...
Psilocybin has shown promise in reducing alcohol use in previous studies, which suggests that it may help reduce craving and other factors that ...
Psilocybin-assisted Therapy for Alcohol Use Disorder
This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control (niacin) in reducing heavy drinking days ...
Evaluating the Effectiveness of Psychedelic-Assisted ...
Psychedelic therapies, particularly those involving psilocybin and LSD, are associated with significant reductions in alcohol consumption, enhanced emotional ...
Psilocybin (Magic Mushrooms) | National Institute on Drug ...
There is no data on the safety of taking ... psilocybin may be helpful in treating substance use disorders, including tobacco use disorder.
Efficacy and safety of psilocybin for the treatment ...
Psilocybin-assisted psychotherapy showed significant reductions in alcohol use and high smoking cessation rates. •. Among 16 studies, most were open-label or ...
Risks and Effects of Mixing Mushrooms and Alcohol
So, while there might not be any inherently adverse interactions from mixing shrooms and alcohol, there still are many unknowns involved.
Classic psychedelics and alcohol use disorders: A systematic ...
Regarding alcohol consumption, no difference was observed between users and nonusers of psilocybin (97% and 96%, respectively). These data suggest ...
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