Cannabis Use DisorderPhase 1NCT06660381
Psilocybin-assisted Treatment for Cannabis Use Disorder
A Phase 1 study testing Psilocybin in people with Cannabis Use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, 21224
About this study
Official title: Pilot Study of Psilocybin-assisted Treatment for Cannabis Use Disorder
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.
Read the detailed description
This pilot study will evaluate the therapeutic potential of psilocybin to produce significant reduction in cannabis use compared to pre-treatment in a sample of 12 treatment-seeking patients with Cannabis Use Disorder (CUD). Upon enrollment, participants will complete a 12-week course of study treatment including two psilocybin sessions, with follow-up assessment 3 and 6 months after the first psilocybin session. After 4 weekly preparatory meetings including a targeted cognitive behavioral therapy (CBT) intervention for CUD, 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. After each psilocybin session, participants will complete a follow-up meeting within 3 days (i.e. integration meeting), as well as continued weekly meetings through week 12. Participants will complete post-session assessments in approximately weeks 12 (End of Treatment), 17 (3 months after 1st psilocybin session, and 29 (6 months after 1st psilocybin session). Some study meetings may be held virtually via a secure web-based video conference platform (e.g., Zoom).
Self-reported cannabis use and biomarkers of recent use will be assessed at baseline (screening), weekly throughout the 12-week intervention, and at approximately weeks 17 (3 months after 1st psilocybin session), and 29 (6 months after 1st psilocybin session).
- Conditions
- Cannabis Use Disorder
- Being tested
- Psilocybin
- Keywords
- cannabis, cannabis dependence
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Open-label psilocybin will be administered with psychological support to each participant at two dosing sessions approximately 2 weeks apart. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months
Secondary outcomes (2)
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.
Measured: Baseline, 3 months
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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start8 Nov 2024
- Primary completion21 Oct 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will undergo two open-label psilocybin dosing sessions (25 mg followed by 25mg or 35 mg).
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Psychedelic and Consciousness Research
- Responsible party
- Sponsor
- Investigators
- Albert Garcia-Romeu, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660381
- Sponsor's protocol ID
- IRB00327911
- Status last verified
- Nov 2026
- First submitted
- 24 Oct 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Psilocybin-assisted Treatment for Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT06660381
- Acronym / sponsor ID
- IRB00327911
- Conditions
- Cannabis Use Disorder
- Keywords
- cannabis, cannabis dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Center for Psychedelic and Consciousness Research
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 21 Oct 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study will evaluate the therapeutic potential of psilocybin to produce significant reduction in cannabis use compared to pre-treatment in a sample of 12 treatment-seeking patients with Cannabis Use Disorder (CUD). Upon enrollment, participants will complete a 12-week course of study treatment including two psilocybin sessions, with follow-up assessment 3 and 6 months after the first psilocybin session. After 4 weekly preparatory meetings including a targeted cognitive behavioral therapy (CBT) intervention for CUD, 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. After each psilocybin session, participants will complete a follow-up meeting within 3 days (i.e. integration meeting), as well as continued weekly meetings through week 12. Participants will complete post-session assessments in approximately weeks 12 (End of Treatment), 17 (3 months after 1st psilocybin session, and 29 (6 months after 1st psilocybin session). Some study meetings may be held virtually via a secure web-based video conference platform (e.g., Zoom).
Self-reported cannabis use and biomarkers of recent use will be assessed at baseline (screening), weekly throughout the 12-week intervention, and at approximately weeks 17 (3 months after 1st psilocybin session), and 29 (6 months after 1st psilocybin session).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will undergo two open-label psilocybin dosing sessions (25 mg followed by 25mg or 35 mg).
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: PsilocybinOpen-label psilocybin will be administered with psychological support to each participant at two dosing sessions approximately 2 weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinParticipants 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. | Drug | Psilocybin |
Primary outcome
Self-reported cannabis use as assessed by a modified Timeline Follow-Back interview
Time frame: Baseline, weekly up to 3 months
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.
Biomarkers of recent cannabis use
Time frame: Baseline, 3 months
Urine samples will be collected and tested for the presence of biomarkers indicating cannabis use.
2 secondary outcomes
Beck Depression Inventory-II (BDI-II) score
Time frame: Baseline, 3 months
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Cannabis Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Garcia-Romeu, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Cannabis Use Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported cannabis use as assessed by a modified Timeline Follow-Back interview (time frame: Baseline, weekly up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.