Psilocybin-assisted Treatment for Cannabis Use Disorder

This study is exploring if psilocybin, a psychedelic compound, can help people with Cannabis Use Disorder (CUD). It's a small pilot study involving 12 participants. You would receive two doses of psilocybin (25mg or 35mg) during a 12-week counseling program. Researchers will measure how much cannabis you use through interviews and by checking for cannabis in your body. To join, you need to be at least 18 years old and have a diagnosis of CUD. The study's current status is unclear, so it's not known if they are actively recruiting.

Study design: This is an open-label (meaning everyone knows what treatment they are getting) pilot study with 12 participants.
What's involved: You would complete a 12-week treatment program with two psilocybin sessions, weekly counseling, and follow-up assessments for up to 6 months after the first psilocybin session.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 3 and 6 months after the first psilocybin session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Psilocybin-assisted Treatment for Cannabis Use Disorder

Recruiting

PHASE1Ages 18+InterventionalTreatment

Johns Hopkins University

~12 participants

Updated 2026-03-18 on ClinicalTrials.gov

What's tested:Psilocybin

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Self-reported cannabis use as assessed by a modified Timeline Follow-Back interview

Measured over Baseline, weekly up to 3 months

+1 more outcome measured

Conditions

Cannabis Use Disorder

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Albert Garcia-Romeu, Ph.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Ian Geithner, MPS

[email protected]

410-550-1972

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 18 years of age.

Capable of providing written informed consent for participation into the study.

Willingness to allow the study team to review past medical records.

Currently meets criteria for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Cannabis Use Disorder.

Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.

Concurrent pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and/or bupropion is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening. Allowable bupropion doses for participants will be ≤300mg/day.

Exclusion

Meeting DSM-5 criteria for another moderate or severe substance use disorder (excluding tobacco) within the past 5 years.

Currently taking antipsychotics, monoamine oxidase (MAO) inhibitors, or antidepressant medications other than SSRIs, SNRIs, or bupropion. Allowable bupropion doses for participants will be ≤300mg/day.

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).

Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or corrected QT interval (QTc) \> 450 msec), transient ischemic attack (TIA) in the last 6 months, stroke, artificial heart valves, or uncontrolled hypertension with resting blood pressure systolic \>139 or diastolic \>89, or heart rate \>90 bpm.

Body weight at screening \<50kg.

Renal disease (creatinine clearance \< 60 ml/min using the Cockraft and Gault equation).

Abnormal screening labs values for hemoglobin, white blood count, creatinine, potassium, and bilirubin outside of the normal lab reference rage.

Transaminases greater than x2 the upper limit of normal lab reference range.

Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.

Family (i.e., 1st degree relative) history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.

Epilepsy with history of seizures.

Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia.

Current dementia or related disorders including but not limited to, Alzheimer's Disease, vascular dementia, Lewy body dementia, and frontotemporal disorders.

Current or past major immunosuppressive illness or medications.

Currently pregnant or nursing.

Currently of childbearing potential and not using effective methods of contraception (i.e., intrauterine systems/devices, hormonal methods including implant, shot, patch, ring, or oral contraceptive, condom, diaphragm, sterilization, abstinence, and fertility-awareness methods).

Not fluent in English.

High risk for suicidal ideation or behavior (i.e., individuals who report suicidal ideation with intent or behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening, or individuals with a suicide attempt within the past 3 years).

What this trial measures

Self-reported cannabis use as assessed by a modified Timeline Follow-Back interviewBaseline, weekly up to 3 months
This information will be collected using a modified Timeline Follow-Back (TLFB) interview. The TLFB (past 30 days), uses a calendar with specific anchor dates to identify the quantity and frequency of use.
Biomarkers of recent cannabis useBaseline, 3 months
Urine samples will be collected and tested for the presence of biomarkers indicating cannabis use.

Trialytics