Cocaine Use DisorderEarly Phase 1NCT06102434
Safety Profile of Psilocybin for Cocaine Use Disorder
A Early Phase 1 study testing Psilocybin in people with Cocaine Use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2029to Jun 2029
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a Body Mass Index from 18.5 - 34kg/m^2
- Score of at least 3 on the Severity of Dependence Scale
- Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence Questionnaire
- At least 1, but not more than 10 total lifetime use of a classical psychedelic (5-HT2a agonist)
- 0 use of a classical psychedelic in the last year
Who cannot join
- History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
- Abnormal electrocardiogram based on testing at study entrance
- A resting heart rate greater than 90 bpm
- Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
- Current use of antidepressants or other serotonergic-affecting substances
- History of cardiac conditions
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- History of hepatic or renal impairments
- History of stroke or Transient Ischemic Attack
- Epilepsy or history of seizures
- Immediate family or personal history of psychosis, bipolar disorder, or schizophrenia
- Anxiety or mood disorders determined by the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V)
- Must not meet DSM-V criteria for any substance use disorders other than cocaine, caffeine, or nicotine
- Must not meet DSM-V criteria for borderline personality or dissociative disorders
- Current suicidal ideation or lifetime history of suicide attempts
- Arrest for a violent offense
- Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
- Women will not be eligible if trying to get pregnant, pregnant, or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder
The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. The study's subject population consists of men and women between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be administered to 10 individuals (separately) during a single laboratory visit. The laboratory visit will take place from 9 am until 3 pm within a comfortable, living room like environment. Within this study session room, participants will be accompanied by two clinicians. Participants will then consume the psilocybin capsule, and thereafter will be encouraged to lie down on a couch and introspect on the experience. At one-hour intervals following ingestion, participants will be tested briefly for changes in heart rate, blood pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is included in the study. Following the laboratory visit, investigators will check-in on participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.
- Conditions
- Cocaine Use Disorder
- Being tested
- Psilocybin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Five oral capsules containing 5 mg of psilocybin each
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | 25 mg psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Beats per minute measured with blood pressure monitor.
Measured: From pre-dose through one-hour intervals post-dose until heart rate has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours.
Blood pressure
Systolic and diastolic blood pressure measured with blood pressure monitor.
Measured: From pre-dose through one-hour intervals post-dose until blood pressure has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours
Self-reported drug effects
Average and peak subjective ratings of drug effects associated with mood measured using visual analogue scales (VAS; 1-100 mm).
Measured: From pre-dose through one-hour intervals post-dose over a 6-bour period.
Secondary outcomes (2)
Self-reported cocaine craving
Average subjective ratings of cocaine craving measured using Cocaine Craving Questionnaire-Brief. Each item on the 10 item questionnaire is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree," with higher scores indicating greater cocaine craving.
Measured: 48 hours and 10, 50, and 90 days after psilocybin administration.
Self-reported mood ratings
Average subjective ratings of Depression, Anxiety, Stress measured using Depression, Anxiety and Stress scales of the Depression Anxiety Stress Scale (DASS-21). Each scale consists of 7 items rated from 0 to 3, with higher scores indicating greater Depression, Anxiety, or Stress.
Measured: 48 hours and 10, 50, and 90 days after psilocybin administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Feb 2029 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionJun 2029 (estimated)
Why it stopped: Departmental support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor Murray, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102434
- Sponsor's protocol ID
- 21-002081
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT06102434
- Acronym / sponsor ID
- 21-002081
- Conditions
- Cocaine Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Departmental support
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2029 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Oct 2023 (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.
The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and subjective (e.g., mood) effects. The study's subject population consists of men and women between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be administered to 10 individuals (separately) during a single laboratory visit. The laboratory visit will take place from 9 am until 3 pm within a comfortable, living room like environment. Within this study session room, participants will be accompanied by two clinicians. Participants will then consume the psilocybin capsule, and thereafter will be encouraged to lie down on a couch and introspect on the experience. At one-hour intervals following ingestion, participants will be tested briefly for changes in heart rate, blood pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is included in the study. Following the laboratory visit, investigators will check-in on participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin25 mg psilocybin |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a Body Mass Index from 18.5 - 34kg/m^2
- Score of at least 3 on the Severity of Dependence Scale
- Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence Questionnaire
- At least 1, but not more than 10 total lifetime use of a classical psychedelic (5-HT2a agonist)
- 0 use of a classical psychedelic in the last year
Key exclusion criteria (17 listed)
- History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
- Abnormal electrocardiogram based on testing at study entrance
- A resting heart rate greater than 90 bpm
- Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
- Current use of antidepressants or other serotonergic-affecting substances
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 |
|---|---|---|
| PsilocybinFive oral capsules containing 5 mg of psilocybin each | Drug | Psilocybin |
Primary outcome
Heart rate
Time frame: From pre-dose through one-hour intervals post-dose until heart rate has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours.
Beats per minute measured with blood pressure monitor.
Blood pressure
Time frame: From pre-dose through one-hour intervals post-dose until blood pressure has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours
Systolic and diastolic blood pressure measured with blood pressure monitor.
Self-reported drug effects
Time frame: From pre-dose through one-hour intervals post-dose over a 6-bour period.
Average and peak subjective ratings of drug effects associated with mood measured using visual analogue scales (VAS; 1-100 mm).
2 secondary outcomes
Self-reported cocaine craving
Time frame: 48 hours and 10, 50, and 90 days after psilocybin administration.
Self-reported mood ratings
Time frame: 48 hours and 10, 50, and 90 days after psilocybin administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin in people with Cocaine Use Disorder, run by University of California, Los Angeles 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 5 inclusion and 17 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: paused, as of the sponsor's last update on 7 Apr 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Heart rate (time frame: From pre-dose through one-hour intervals post-dose until heart rate has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours.). The study lists 3 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 7 Apr 2026.