psilocybin for Alcohol Dependency

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alcohol Dependency+1 More
Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data. Participants will receive psilocybin orally in two all-day administration sessions, conducted in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in recent studies. Psilocybin administration will occur in the context of a behavioral intervention including a total of 12 sessions over 12 weeks, incorporating Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before and debriefing after the psilocybin administration sessions. The MET will incorporate attention to spirituality as well as drinking behavior as a primary subject of change. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured during treatment and for 24 weeks after the end of treatment. The investigators hypothesize that drinking will decrease following the psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks vs. baseline) will be observed among study participants.

Eligible Conditions
  • Alcohol Dependency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alcohol Dependency

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Week 12
change in percent heavy drinking days

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Alcohol Dependency

Side Effects for

Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Insomnia
6%Depressed mood
4%Alcohol poisoning
4%Pneumonia
4%Viral upper resp. tract infection
4%Depression
4%Corona virus infection
4%Vomiting
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Musculoskeletal pain
2%Dizziness
2%Pain
2%Limb injury
2%Abdominal pain
2%Blood pressure increased
2%Urinary incontinence
2%Cataract
2%Testicular pain
2%Toothache
2%Illusion
2%Fatigue
2%Psychomotor hyperactivity
2%Skin cosmetic procedure
2%Food allergy
2%Muscle strain
2%Back pain
2%Food poisoning
2%Alcohol withdrawal syndrome
2%Dysphoria
2%Nasal congestion
2%Photopsia
2%Myalgia
2%Palpitations
2%Dyspepsia
2%Biopsy cervix
2%Gingivitis
2%Diverticulitis
2%Asthenia
2%Influenza
2%Oropharyngeal pain
2%Hyperventilation
2%Blood pressure diastolic increased
2%Dyspnea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Psilocybin ARM group. Side effects include: Headache with 44%, Nausea with 21%, Anxiety with 15%, Suicidal Ideation with 8%, Insomnia with 6%.

Trial Design

1 Treatment Group

psilocybin
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: psilocybin · No Placebo Group · Phase 2

psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Who is running the clinical trial?

Heffter Research InstituteOTHER
13 Previous Clinical Trials
500 Total Patients Enrolled
1 Trials studying Alcohol Dependency
95 Patients Enrolled for Alcohol Dependency
University of New MexicoLead Sponsor
338 Previous Clinical Trials
3,536,882 Total Patients Enrolled
4 Trials studying Alcohol Dependency
305 Patients Enrolled for Alcohol Dependency
Michael P Bogenschutz, M.D.Principal InvestigatorUniversity of New Mexico

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Illinois11.1%
Kansas11.1%
North Carolina11.1%
Other66.7%
How old are they?
18 - 65100.0%
What site did they apply to?
University of New Mexico Health Sciences Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%