Psilocybin-assisted Treatment for Cannabis Use Disorder

NCT06660381 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00327911
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cannabis Use Disorder

Keywords

cannabis; cannabis dependence

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline, weekly up to 3 months

• Biomarkers of recent cannabis use

  Urine samples will be collected and tested for the presence of biomarkers indicating cannabis use.

  Baseline, 3 months

Secondary Outcomes (2)

• Beck Depression Inventory-II (BDI-II) score

  Baseline, 3 months

• Pittsburgh Sleep Quality Index (PSQI) score

  Baseline, 3 months

Study Arms (1)

Psilocybin

EXPERIMENTAL

Open-label psilocybin will be administered with psychological support to each participant at two dosing sessions approximately 2 weeks apart.

Drug: Psilocybin

Interventions

Psilocybin DRUG

Participants will receive a moderately high dose (25mg) of psilocybin in week 5 of the 12-week counseling, and either another moderately high dose (25mg) or a high dose (35mg) in week 7.

Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Center for Psychedelic and Consciousness Research: collaborator

Study Sites (1)

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Albert Garcia-Romeu, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Geithner, MPS

CONTACT

410-550-1972; igeithn1@jhmi.edu

Albert Garcia-Romeu, PhD

CONTACT

agarci33@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking, open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will undergo two open-label psilocybin dosing sessions (25 mg followed by 25mg or 35 mg).

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)