Clinical TrialSubstance Use Disorders (SUD)PsilocybinRecruiting

Psilocybin-assisted Treatment for Cannabis Use Disorder

Open-label proof-of-concept trial (n=12) of two psilocybin sessions (25 mg then 25 mg or 35 mg) with psychological support for treatment-seeking people with Cannabis Use Disorder across a 12‑week course.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This pilot, single-group study will test whether two supervised psilocybin sessions delivered within a 12-week counselling programme reduce cannabis use in 12 participants with Cannabis Use Disorder.

Participants complete four weekly preparatory meetings including a targeted CBT intervention, a psilocybin session (25 mg) in week 5 and a second session (25 mg or 35 mg) in week 7, with integration meetings and weekly follow-up through week 12 and assessments at 3 and 6 months.

Study Protocol

Preparation

4 sessions

Dosing

2 sessions

Integration

2 sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Psilocybin

experimental

Open-label two psilocybin dosing sessions with psychological support approximately 2 weeks apart within a 12-week counselling course.

Interventions

  • Psilocybin25 - 35 mg
    via Oral• two sessions• 2 doses total

    25 mg in week 5; second session in week 7 at 25 mg or 35 mg.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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 Cockcroft and Gault equation).
  • Abnormal screening labs values for hemoglobin, white blood count, creatinine, potassium, and bilirubin outside of the normal lab reference range.
  • 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 Details

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States

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