NCT06660381 Psilocybin-assisted Treatment for Cannabis Use Disorder
| NCT ID | NCT06660381 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Cannabis Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-11-08 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Albert Garcia-Romeu, Ph.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06660381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cannabis Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06660381 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06660381 currently recruiting?
Yes, NCT06660381 is actively recruiting participants. Contact the research team at igeithn1@jhmi.edu for enrollment information.
Where is the NCT06660381 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06660381 clinical trial?
NCT06660381 is sponsored by Johns Hopkins University. The principal investigator is Albert Garcia-Romeu, Ph.D. at Johns Hopkins University. The trial plans to enroll 12 participants.