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Psilocybin-assisted Treatment for Cannabis Use Disorder

ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: PsilocybinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, weekly up to 3 months
2

Biomarkers of recent cannabis use

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

Time frame
Baseline, 3 months

Secondary outcomes

1

Beck Depression Inventory-II (BDI-II) score

The BDI-II is a widely-used, 21-item measure of cognitive and vegetative depressive symptoms. It has good reliability and validity, and can be scored to include as well as exclude somatic symptoms. The total score can range from 0 to 63, with higher scores indicating more severe symptoms.

Time frame
Baseline, 3 months
2

Pittsburgh Sleep Quality Index (PSQI) score

The PSQI is a 19-item self-report inventory that provides measures of daytime dysfunction; sleep latency, duration, disturbance, quality and efficiency. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Center for Psychedelic and Consciousness Research

Collaborator

Source ClinicalTrials.gov
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