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Psychedelic Therapy

Psilocybin for Cannabis Use Disorder

Phase 1
Recruiting
Led By Albert Garcia-Romeu, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age
Be older than 18 years old
Must not have
Currently taking lithium or other primary centrally-acting serotonergic medications, whether over-the-counter or prescription (e.g., efavirenz, 5-hydroxytryptophan, St. John's wort)
Current dementia or related disorders including but not limited to, Alzheimer's Disease, vascular dementia, Lewy body dementia, and frontotemporal disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly up to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how psilocybin, a compound found in certain mushrooms, can help people with Cannabis Use Disorder (CUD). 12 participants with CUD will undergo a 12

Who is the study for?
This trial is for individuals who struggle with Cannabis Use Disorder, meaning they have a problematic pattern of cannabis use. Participants will be involved in a 12-week study with follow-ups at 3 and 6 months after treatment begins.
What is being tested?
The trial is testing the effects of psilocybin, which is thought to potentially help treat Cannabis Use Disorder. It includes two sessions where psilocybin is administered with psychological support over a course of 12 weeks.
What are the potential side effects?
Psilocybin can cause various side effects such as changes in perception, mood swings, dizziness, headaches, nausea and could potentially lead to psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that affects my brain's serotonin levels.
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I do not have dementia or related disorders like Alzheimer's.
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My body weight is less than 50kg.
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I have or had a major illness that affects my immune system or I take medications that weaken my immune system.
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I am of childbearing age and not using birth control.
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My kidney function is reduced with a creatinine clearance below 60 ml/min.
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I do not have serious heart issues like uncontrolled high blood pressure, recent stroke, or irregular heartbeat.
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I have epilepsy with a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weekly up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biomarkers of recent cannabis use
Self-reported cannabis use as assessed by a modified Timeline Follow-Back interview
Secondary study objectives
Beck Depression Inventory-II (BDI-II) score
Pittsburgh Sleep Quality Index (PSQI) score

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
Open-label psilocybin will be administered with psychological support to each participant at two dosing sessions approximately 2 weeks apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,759 Total Patients Enrolled
Center for Psychedelic and Consciousness ResearchUNKNOWN
Albert Garcia-Romeu, Ph.D.Principal InvestigatorJohns Hopkins University
~8 spots leftby Mar 2026
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