HealthyPhase 1NCT02163707
UW Psilocybin Pharmacokinetics Study
A Phase 1 study testing Psilocybin in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Psilocybin (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first isolated from Psilocybe mushrooms in 1957. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- Jun 2014to Dec 2015
- Phase
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21 - 80 years
- Able to read, speak, and understand spoken English
- Self-report of at least one prior positive hallucinogen drug experience that included a meaningful altered state of consciousness. Hallucinogenic substances can include psilocybin, LSD, or other classic hallucinogens.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 based upon CRU NP or study physician physical exam, which indicates a subject is fully functioning.
- A woman of childbearing potential must agree to practice an effective means of birth control during their participation in the clinical trial, up to and including the 90 day follow-up after their last psilocybin dose. Birth control method and written agreement to practice this method throughout the duration of the study will be documented on the Medical History Case Report Form. Effective contraception is defined as the regular use of one of the following:
- Established use of oral, injected, or implanted hormonal methods of contraception
Show all 15Show fewer
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods: Condom or Occlusive cap used with a spermicide
- female sterilization/hysterectomy (with documentation of surgery)
- post-menopausal (>12 months since last menses at the time of screening)
- Male sterilization (with post-vasectomy documentation)
- True abstinence
- Ability and willingness to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and tobacco, within 24 hours of each drug administration. The exception is caffeine.
- Participants will be required to be non-smokers.
Who cannot join
- Estimated creatinine clearance <30 ml/min, using the Cockcroft Gault equation and actual body weight.
- Clinically significant abnormal chemistry or hematologic laboratory results (from a screen of Complete Blood Count with Differential and Comprehensive Metabolic Panel), using the UWHC core lab reference intervals.
- Females of childbearing potential with positive urine pregnancy at screening or the day of the first treatment.
- Clinically significant abnormalities in physical examination.
- Inadequately treated hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg).
- Personal history of primary psychotic disorder (unless substance-induced or due to a medical condition), bipolar affective disorder Type I or Type II, or schizophrenia.
Show all 32Show fewer
- First or second-degree family history of primary psychotic disorder, bipolar affective disorder Type I, bipolar affective disorder Type II, or schizophrenia.
- Substance abuse or dependency within the past five years.
- Suicidal ideation or attempt within the past 30 days and/or any prior suicidal ideation/attempt that the study physician and PI feel makes the participant unsuitable for the study.
- Urine drug test containing non-prescribed drugs of abuse (non-prescribed opioids, benzodiazepines, amphetamines, phencyclidine, cocaine) at screening and day of first treatment. Urine cannabinoid concentrations >50 ng/ml will suggest heavy marijuana use, and will be a threshold for excluding potential subjects.
- Current use of monoamine oxidase inhibitors or dopaminergic antagonists. Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug.
- Subject does not have a local support person that is available during their 24 hour treatment and observation period.
- Concurrent or recent (within 5 years) history of major depression, obsessive-compulsive disorder, panic disorder, anorexia nervosa, or bulimia nervosa.
- Poor venous access.
- Known acute coronary syndrome or angina.
- Evidence of ischemic disease or ventricular arrhythmias on screening ECG.
- Cardiac conduction defects on screening ECG.
- Cardiac transplantation as determined by self-report during review of medical history.
- Lactose intolerance (excipient in psilocybin capsules)
- Type I or insulin-dependent Type II diabetes.
- Prescription medicine requiring dosing during the 8 hours of drug action.
- Current or recent (past 5 years) seizure disorder as determined by self-report during medical history and physical exam.
- Chronic or frequent migraines.
- Regular or frequent use of benzodiazepines.
- Attention Deficit Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD).
- Regular or frequent use of stimulants.
- Generalized Anxiety Disorder (GAD).
- Post-Traumatic Stress Disorder (PTSD).
- Neuroleptic medications.
- Any physical or psychological symptom, based on the clinical judgment of the study physician and/or psychologist , that would make a participant unsuitable for the study.
- Any use of a medication(s), based on the clinical judgment of the study physician, that would make a participant unsuitable for the study.
- Any finding(s), based on the screening process, that the PI feels makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, School of Pharmacy
Madison, Wisconsin, 53705
About this study
Official title: Pharmacokinetics of Psilocybin in Normal Adult Volunteers
Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Psilocybin (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The study is performed in support of Phase II and Phase III studies of psilocybin for the treatment of refractory anxiety associated with incurable cancer, as well as other possible indications. Psilocybin is at present not an FDA-approved drug.
Read the detailed description
The primary objective of this clinical trial is to determine the pharmacokinetics of an extemporaneous oral formulation of psilocybin in normal, healthy adults. This study is intended to add to the existing body of modern clinical research on psilocybin to support future multi-institutional Phase III clinical trials seeking to decrease anxiety and depression in patients with incurable cancer. The long-term goal of this research is to submit a successful new drug application for psilocybin to the FDA.
Subjects will initially take one 0.3 mg/kg (approximately 20mg/70kg) oral dose of psilocybin to initiate an eight hour chaperoned outpatient experience. After eight hours of outpatient sampling, the subject will be transported across the street to the UW Institute for Clinical and Translational Research Clinical Research Unit (ICTR CRU) for an overnight stay and additional blood and urine sampling. Pre- and post-treatment psychologic preparation and debriefing interviews will be required.
A minimum of four weeks after the first dose, the subject will receive a second oral dose of psilocybin at the higher dose of 0.45 mg/kg (approximately 30 mg/70 kg). This dosing will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours). A minimum of four weeks after the second dose, the subject will receive a third oral dose of psilocybin at the highest dose of 0.6 mg/kg (approximately 40 mg/70 kg). This dose will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours).
12-lead ECGs will be obtained at specified time points before and during each treatment period. Throughout the duration of drug action for each dose participants will be attended by two trained monitors, and a physician will available during the entire 24 hour treatment and sampling period.
Subjects who have been administered the first dose but decline to receive any subsequent doses will remain evaluable. At that time their active study participation will end.
- Conditions
- Healthy
- Being tested
- Psilocybin
- Keywords
- Psilocybin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Dose 1: 0.3 mg/kg (approximately 20mg/70kg) Dose 2: 0.45 mg/kg (approximately 30 mg/70 kg) Dose 3: 0.6 mg/kg (approximately 40 mg/70 kg)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Dose 1 | Other | 0.3 mg/kg (approximately 20mg/70kg) Receives: Drug: Psilocybin |
| Psilocybin Dose 2 | Other | 0.45 mg/kg (approximately 30 mg/70 kg) Receives: Drug: Psilocybin |
| Psilocybin Dose 3 | Other | 0.6 mg/kg (approximately 40 mg/70 kg) Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the concentrations of psilocin following escalating doses of psilocybin
Determine the AUC of psilocin in plasma following single doses of 0.3, 0.45, and 0.6 mg/lg psilocybin, the precursor to psilocin.
Measured: 12 months
Secondary outcomes (3)
Characterize any non-linearity in the pharmacokinetics of psilocybin and psilocin.
Quantitate any non-linearity of the plasma AUC of psilocybin and its active metabolite psilocin after escalation doses of psilocybin.
Measured: 12 months
Determine the effect of kidney function on psilocin pharmacokinetics.
Use urine and plasma collections to quantitate the relative renal clearance of creatinine and psilocin to characterize the dependency of renal clearance of psilocin upon the glomerular filtration rate. Variation in renal function will arise from the range of ages in subjects; subjects are not selected or grouped based upon renal function.
Measured: 12 months
Characterize the incidence and severity of adverse events associated with escalating doses of psilocybin in normal adults.
The incidence and severity of expected and unexpected adverse events will be collected using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v4 during and in treatment follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Hutson, PharmD, Principal investigator, University of Wisconsin, School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163707
- Sponsor's protocol ID
- 2013-0998
- Other IDs
- A561000, PHARM\PHARMACY\PHARMACY
- Status last verified
- Apr 2020
- First submitted
- 3 Jun 2014
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.
PubMed 28353056Nicholas CR, Henriquez KM, Gassman MC, Cooper KM, Muller D, Hetzel S, Brown RT, Cozzi NV, Thomas C, Hutson PR. High dose psilocybin is associated with positive subjective effects in healthy volunteers. J Psychopharmacol. 2018 Jul;32(7):770-778. doi: 10.1177/0269881118780713. Epub 2018 Jun 27.
PubMed 29945469
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Psilocybin in Normal Adult Volunteers
- ClinicalTrials.gov ID
- NCT02163707
- Acronym / sponsor ID
- 2013-0998
- Conditions
- Healthy
- Keywords
- Psilocybin, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Jun 2014 (estimated)
- 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.
Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Psilocybin (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The study is performed in support of Phase II and Phase III studies of psilocybin for the treatment of refractory anxiety associated with incurable cancer, as well as other possible indications. Psilocybin is at present not an FDA-approved drug.
Detailed description
The primary objective of this clinical trial is to determine the pharmacokinetics of an extemporaneous oral formulation of psilocybin in normal, healthy adults. This study is intended to add to the existing body of modern clinical research on psilocybin to support future multi-institutional Phase III clinical trials seeking to decrease anxiety and depression in patients with incurable cancer. The long-term goal of this research is to submit a successful new drug application for psilocybin to the FDA.
Subjects will initially take one 0.3 mg/kg (approximately 20mg/70kg) oral dose of psilocybin to initiate an eight hour chaperoned outpatient experience. After eight hours of outpatient sampling, the subject will be transported across the street to the UW Institute for Clinical and Translational Research Clinical Research Unit (ICTR CRU) for an overnight stay and additional blood and urine sampling. Pre- and post-treatment psychologic preparation and debriefing interviews will be required.
A minimum of four weeks after the first dose, the subject will receive a second oral dose of psilocybin at the higher dose of 0.45 mg/kg (approximately 30 mg/70 kg). This dosing will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours). A minimum of four weeks after the second dose, the subject will receive a third oral dose of psilocybin at the highest dose of 0.6 mg/kg (approximately 40 mg/70 kg). This dose will again take place in an attended, structured setting with timed blood and urine samples obtained both in the School of Pharmacy (0-8 hours) and in the UW Clinical Research Unit (8-24 hours).
12-lead ECGs will be obtained at specified time points before and during each treatment period. Throughout the duration of drug action for each dose participants will be attended by two trained monitors, and a physician will available during the entire 24 hour treatment and sampling period.
Subjects who have been administered the first dose but decline to receive any subsequent doses will remain evaluable. At that time their active study participation will end.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Dose 1 | Other | Drug: Psilocybin0.3 mg/kg (approximately 20mg/70kg) |
| Psilocybin Dose 2 | Other | Drug: Psilocybin0.45 mg/kg (approximately 30 mg/70 kg) |
| Psilocybin Dose 3 | Other | Drug: Psilocybin0.6 mg/kg (approximately 40 mg/70 kg) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 21 - 80 years
- Able to read, speak, and understand spoken English
- Self-report of at least one prior positive hallucinogen drug experience that included a meaningful altered state of consciousness. Hallucinogenic substances can include psilocybin, LSD, or other classic hallucinogens.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 based upon CRU NP or study physician physical exam, which indicates a subject is fully functioning.
- A woman of childbearing potential must agree to practice an effective means of birth control during their participation in the clinical trial, up to and including the 90 day follow-up after their last psilocybin dose. Birth control method and written agreement to practice this method throughout the duration of the study will be documented on the Medical History Case Report Form. Effective contraception is defined as the regular use of one of the following:
Key exclusion criteria (32 listed)
- Estimated creatinine clearance <30 ml/min, using the Cockcroft Gault equation and actual body weight.
- Clinically significant abnormal chemistry or hematologic laboratory results (from a screen of Complete Blood Count with Differential and Comprehensive Metabolic Panel), using the UWHC core lab reference intervals.
- Females of childbearing potential with positive urine pregnancy at screening or the day of the first treatment.
- Clinically significant abnormalities in physical examination.
- Inadequately treated hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg).
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 |
|---|---|---|
| PsilocybinDose 1: 0.3 mg/kg (approximately 20mg/70kg) Dose 2: 0.45 mg/kg (approximately 30 mg/70 kg) Dose 3: 0.6 mg/kg (approximately 40 mg/70 kg) | Drug | Psilocybin Dose 1, Psilocybin Dose 2, Psilocybin Dose 3 |
Primary outcome
Determine the concentrations of psilocin following escalating doses of psilocybin
Time frame: 12 months
Determine the AUC of psilocin in plasma following single doses of 0.3, 0.45, and 0.6 mg/lg psilocybin, the precursor to psilocin.
3 secondary outcomes
Characterize any non-linearity in the pharmacokinetics of psilocybin and psilocin.
Time frame: 12 months
Determine the effect of kidney function on psilocin pharmacokinetics.
Time frame: 12 months
Characterize the incidence and severity of adverse events associated with escalating doses of psilocybin in normal adults.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Results publication: PubMed 28353056Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.
- Results publication: PubMed 29945469Nicholas CR, Henriquez KM, Gassman MC, Cooper KM, Muller D, Hetzel S, Brown RT, Cozzi NV, Thomas C, Hutson PR. High dose psilocybin is associated with positive subjective effects in healthy volunteers. J Psychopharmacol. 2018 Jul;32(7):770-778. doi: 10.1177/0269881118780713. Epub 2018 Jun 27.
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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.
Paul Hutson, PharmD principal investigator
University of Wisconsin, School of Pharmacy
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 Healthy, run by University of Wisconsin, Madison 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 15 inclusion and 32 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: finished, as of the sponsor's last update on 15 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the concentrations of psilocin following escalating doses of psilocybin (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163707, which also lists 2 linked publications.
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 15 Apr 2020.