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Psychedelic ExperiencesPhase 1RECAPNCT04842045

Pilot RECAP Study in Healthy Volunteers

A Phase 1 study testing Psilocybin and Midazolam in people with Psychedelic Experiences and Amnesia, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Psychedelic Experiences, Amnesia
What is being tested?
Psilocybin and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
21 May 2021to 17 Nov 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 21 to 65 years at screening
  • Medically healthy (does not meet criteria for an exclusionary medical condition)
  • No current DSM-5 psychiatric diagnosis
  • No current use of psychotropic medications
  • Ability/willingness to complete all study activities
  • Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)
Show all 9Show fewer
  • Speaks and reads English
  • No use of psychedelic drugs within prior 3 months of dosing visit
  • Able to swallow oral medications

Who cannot join

  • Pregnancy
  • Current exclusionary medical illness
  • Current DSM-5 psychiatric diagnosis and/or suicidal thoughts/behavior within prior 12 months
  • Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
  • Clinically significant electrocardiogram (ECG)
  • Hypertension or tachycardia
  • First degree relative(s) with a history of schizophrenia, schizophreniform disorder, bipolar I disorder, bipolar II disorder, major depressive disorder with psychotic features

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UWHealth, 600 Highland Avenue

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Recall of Experience and Conscious Awareness in Psilocybin Treatment of Depression (The RECAP Study): Pilot Phase in Healthy Adult Volunteers

The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study.

Read the detailed description

The PILOT RECAP Study will investigate the effect of co- administering the amnestic agent midazolam with a single 25 mg dose of psilocybin on the induction of a psychedelic experience and subsequent memory for the experience with the goal of identifying an optimal dosing regimen of midazolam that will allow a psychedelic experience to occur while also inducing amnesia for the experience. Identifying this midazolam dosing regimen will allow us in a subsequent stage of the RECAP program to test whether memory for the psychedelic experience is required/important for psilocybin to produce longer-term antidepressant effects. This is a phase 1 study in psychiatrically and medically healthy volunteers. Given this, there is no disease background for PILOT RECAP per se. However, the purpose of PILOT RECAP is to identify an optimal midazolam dosing schedule to be used in a subsequent study (RECAP) in patients with major depressive disorder (MDD).

The investigational treatment for PILOT RECAP is a single 25 mg dose of psilocybin combined with repeated intravenous (IV) boluses of midazolam dosed at levels known to maintain conscious experience while inducing subsequent amnesia for the experience upon its conclusion. Because PILOT RECAP is the first study to examine this drug combination, no data are currently available on this approach. Psilocybin + midazolam will be administered within a "Set and Setting" (SaS) protocol that provides psychoeducation and therapeutic support prior to, during, and following psychedelic dosing, and that has been standard procedure for recent studies of psilocybin in humans. It is believed that this SaS approach enhances clinical efficacy and safety. SaS is an integral component of the PILOT RECAP intervention.

The PILOT RECAP study will not enroll vulnerable populations. During this study, participants are asked to:

  • Refrain from use of psychotropic medications. Use of such medications prior to psilocybin/midazolam dosing will result in a participant being discontinued from the study.
  • Refrain from use of any illegal psychoactive substances from screening until study termination.
  • Refrain from using legal psychoactive substance for the following defined time periods (the exception is caffeine):
  • Tobacco and Nicotine: from screening until study termination
  • Alcohol: 72 hours prior to the Dosing Visit
Being tested
Psilocybin and Midazolam
Keywords
Memory, Amnesia, Healthy Volunteer
Medical subject headings
Amnesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psilocybin and MidazolamDrug

    Also called Psilocybine, Psilocibin, benzodiazepine

    The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin.

    The midazolam in this study will be administered intravenously. The total dose administered to a given subject is dependent on the individual's level of amnesia, sedation scale score, age, and weight.

Study groups in NCT04842045
Study groupRoleWhat they receive
Single ArmExperimentalMedically and psychiatrically healthy adults ages 21 to 65 years will receive a single 25 mg dose of psilocybin combined with repeated boluses of midazolam administered in a clinically supportive setting.
Receives: Drug: Psilocybin and Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants scoring >50 percent of normative scores on selected questions from the Altered States of Consciousness (ASC) questionnaire asked during the dosing session Day 0.

    Participants will complete a selection of several questions from the ASC questionnaire that strongly associate positively or negatively with later antidepressant effect of psilocybin in patients with treatment resistant depression or capture classic features of the psychedelic experience.

    During the dosing session, investigator will repeatedly ask selected items from the ASC scale to get a "real time" measure of what the participants are experiencing. Each of these items will be scored separately. Higher score are indicative of a more intense psychedelic experience.

    Measured: On Day 14

  2. Number of participants scoring < 50 percent on post-dosing Day 1 of the mean normative score of ASC data from healthy volunteers administered the ASC questionnaire post-dosing

    To assess the degree to which midazolam has induced amnesia for the psychedelic experience, participants will complete the full ASC.

    The ASC is a 94 item questionaire. In response to each item, participants are asked to mark their experience somewhere between 'No, not more than usual' to 'Yes, much more than usual'. Normal waking consciousness corresponds to a mark at the very left end of the scale, i.e. 'No, Not more than usual'.

    Responses marked more towards right side of the range are considered high on psychedelic experience.

    Measured: On Day 15

Secondary outcomes (7)

  1. Accuracy on post-dosing Day 1 in recognizing ASC items asked during the dosing session Day 0 (number of correct versus distractor items)

    Participants will undergo a yes-no ASC recognition task regarding their memory for internally and externally focused phenomenological content of their experience.

    Measured: On Day 15

  2. Safety of psilocybin-midazolam co-administration assessed by number of adverse event incidences in each severity grade.

    Adverse event grading will be done using Common Terminology Criteria for Adverse Event (CTCAE)Adverse events will be graded from Grade 1-5 depending on severity. Grade 1 - mild, grade 2 - moderate, grade 3 - severe, grade 4 - Life threatening, grade 5 - Fatal. Adverse events will be collected on an Adverse Event Log throughout the study.

    Measured: up to 4 weeks

  3. Safety of psilocybin-midazolam co-administration assessed by number of participants requiring medical attention due to adverse events

    Measured: up to 4 weeks

  4. Safety of psilocybin-midazolam co-administration assessed by number of participants requiring psychiatric attention due to adverse events

    Measured: up to 4 weeks

  5. Safety of psilocybin-midazolam co-administration assessed by number of participants leading to withdrawal from study due to adverse events

    Measured: up to 4 weeks

  6. Safety of psilocybin-midazolam co-administration assessed by number of participants with severe adverse events

    Measured: up to 4 weeks

  7. Safety of psilocybin-midazolam co-administration assessed by number of participants with new concomitant medication due to adverse events

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2021
  2. Study start21 May 2021
  3. Primary completion17 Nov 2022
  4. Study completion17 Nov 2022

Resources

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
Open trial of a single 25 mg dose of psilocybin combined with repeated boluses of midazolam in medically and psychiatrically healthy volunteers.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842045
Sponsor's protocol ID
2020-0085
Other IDs
A532017, SMPH/FAMILY MEDICINE, AAH3816, PROTOCOL V7.0 10 OCT 2021
Acronym
RECAP
Status last verified
May 2023
First submitted
1 Apr 2021
Last updated
19 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Psilocybin and Midazolam in people with Psychedelic Experiences and Amnesia, 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 9 inclusion and 7 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 19 May 2023. 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?

Number of participants scoring >50 percent of normative scores on selected questions from the Altered States of Consciousness (ASC) questionnaire asked during the dosing session Day 0. (time frame: On Day 14). 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?

On the ClinicalTrials.gov record for NCT04842045.

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 19 May 2023.

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