Actively Recruiting
Psilocybin-assisted Treatment for Cannabis Use Disorder
Led by Johns Hopkins University · Updated on 2026-03-18
12
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Center for Psychedelic and Consciousness Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This pilot study will evaluate the therapeutic potential of psilocybin in people with Cannabis Use Disorder (CUD). This study will examine the impact of psilocybin treatment on cannabis use and related variables in 12 people with CUD. This is an open-label proof-of-concept trial in which participants will complete a 12-week course of study treatment including two psilocybin sessions with psychological support, and follow-up assessments 3 and 6 months after the first psilocybin session.
CONDITIONS
Official Title
Psilocybin-assisted Treatment for Cannabis Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able to provide written informed consent to participate
- Willing to allow review of past medical records by study team
- Currently diagnosed with Cannabis Use Disorder according to DSM-5 criteria
- Medically stable as determined by interview, medical questionnaire, physical exam, ECG, and routine lab tests
- If taking SSRIs, SNRIs, and/or bupropion, treatment must be stable for at least 2 months before screening
- Bupropion dose must be 300 mg/day or less
You will not qualify if you...
- Diagnosis of another moderate or severe substance use disorder (excluding tobacco) within past 5 years
- Taking antipsychotics, MAO inhibitors, or antidepressants other than SSRIs, SNRIs, or bupropion (bupropion dose must be 300 mg/day or less)
- Taking lithium or other primary centrally-acting serotonergic medications
- Cardiovascular conditions such as angina, significant ECG abnormalities, recent TIA or stroke, artificial heart valves, uncontrolled high blood pressure, or heart rate over 90 bpm
- Body weight under 50 kg at screening
- Renal disease with creatinine clearance below 60 ml/min
- Abnormal lab values outside normal reference ranges for hemoglobin, white blood count, creatinine, potassium, bilirubin, or elevated transaminases
- Current or past diagnosis of schizophrenia, psychotic disorders (unless substance-induced or medical), or bipolar I or II disorder
- Family history of schizophrenia, psychotic disorders (unless substance-induced or medical), or bipolar I disorder
- History of epilepsy with seizures
- Insulin-dependent diabetes or history of hypoglycemia if taking oral diabetes medication
- Current dementia or related disorders
- Major immunosuppressive illness or medications
- Currently pregnant or nursing
- Of childbearing potential and not using effective contraception
- Not fluent in English
- High risk for suicidal ideation or behavior, including recent suicide attempts or intent on screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
I
Ian Geithner, MPS
CONTACT
A
Albert Garcia-Romeu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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