Recruiting
Phase 1

Psilocybin-assisted Treatment

Sponsor:

Johns Hopkins University

Code:

NCT06660381

Conditions

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Study Details

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

Study ID

NCT06660381

Start date

Nov 8, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 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 Criteria:

  • 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).

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin

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

Interventions

Psilocybin

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.

Primary outcome measure

  • Self-reported cannabis use as assessed by a modified Timeline Follow-Back interview [ Time Frame: Baseline, weekly up to 3 months ]
  • Biomarkers of recent cannabis use [ Time Frame: Baseline, 3 months ]

Central Contacts and Locations

Central contacts

Ian Geithner, MPS

410-550-1972igeithn1@jhmi.edu

Albert Garcia-Romeu, PhD

agarci33@jhmi.edu

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Ian Geithner, MPS

786-239-7990agromeu77@gmail.com

Albert Garcia-Romeu, PhD

agarci33@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • cannabis
  • cannabis dependence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-18.