Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-11-18
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Psilocybin Therapy
The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and four final integration sessions
Psilocybin
The psilocybin will include two dose administration sessions, first a 20mg administration, and second an administration of up to 25mg.
Preparation and Integration Sessions
The psilocybin therapy will include three preparatory sessions, two dose A integration sessions, and four final integration sessions.
Interventions
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Psilocybin
The psilocybin will include two dose administration sessions, first a 20mg administration, and second an administration of up to 25mg.
Preparation and Integration Sessions
The psilocybin therapy will include three preparatory sessions, two dose A integration sessions, and four final integration sessions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 18 and 25 years old at time of screening.
* Meets Diagnostic and Statistical Manual (DSM-5) criteria for any type of Anorexia Nervosa
* Currently experiencing symptoms of Anorexia Nervosa
* Comfortable reading and writing in English
* Have no anticipated changes in medication or surgical procedures for trial duration
* Commit to attend all in-person and remote study visits and participate in all data collection procedures
* Able to identify one or two family members or close friends to co-enroll in the study, who will be required to participate in select therapy sessions.
* Agree to use a highly effective form of contraception for two weeks prior to starting the study and one month after finishing the study.
* Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
* Agree to consume approximately the same amount of caffeine-containing beverages (e.g., coffee, tea) that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions. If the young adult participant does not routinely consume caffeinated beverages, they must agree not to do so prior to psilocybin administration sessions.
Exclusion Criteria
* Personal history of bipolar disorder, or psychotic disorder verified by the Structured Clinical Interview for DSM-5 (SCID) and medical history at screening
* Body Mass Index less than 12 at screening
* Unstable vital signs including Blood Pressure, Heart Rate, or Temperature
* Abnormal Safety Labs including sodium, potassium, magnesium, phosphorus, creatinine, estimated Glomerular Filtration Rate, Aspartate Transferase, Alanine Transaminase
* Electrocardiogram abnormalities
* Hospitalization or participation in a residential program for more than 2 of the past 4 weeks at the time of screening.
* Unwilling to abstain from alcohol, Cannabidiol (CBD), tetrahydrocannabinol (THC), marijuana, and illicit drug use for 48 hours pre and post psilocybin dosing days and abstain from nicotine for 10 hours pre and post psilocybin dosing.
* Positive urine toxicology testing for amphetamines, benzodiazepines, cocaine, cannabis, 3,4-Methylenedioxymethamphetamine (MDMA), and opioids (including methadone and buprenorphine) on the morning of either psilocybin administration session.
* History of cardiovascular disease
* Uncontrolled endocrine conditions, including diabetes, hyper or hypothyroidism
* Significant and uncontrolled gastrointestinal illness at the discretion of the investigator
* Significant and uncontrolled neurological disease including uncontrolled seizure disorder at the discretion of the investigator
* Use of any prohibited concomitant medications or inability or unwillingness to discontinue according to the study's prescribed medication taper or tapering with the participants primary prescriber.
* Needle phobia.
* Simultaneous enrollment in another clinical trial.
* Pregnant or Breast feeding.
* Allergy or intolerance to any of the materials contained in the drug product
* History of severe reaction to psychedelics at the discretion of the investigators.
* High risk of self-harm/suicide
* Mental health condition that will prevent engagement with the treatment team.
* Unwilling or unable to participate in the treatment protocol as planned, including hydration with sports drinks on dosing days.
* If any study physician feels that it would be unsafe to continue for any mental, physical or other reason
18 Years
25 Years
ALL
No
Sponsors
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Marissa Raymond-Flesch, MD, MPH
OTHER
Responsible Party
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Marissa Raymond-Flesch, MD, MPH
Professor, Pediatrics
Principal Investigators
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Marissa Raymond-Flesch, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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23-39236
Identifier Type: -
Identifier Source: org_study_id
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