Health TrialsbyHealthPanel

Mindfulness-Assisted Psychedelic Therapy

ConditionMental Health
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Southern California

About this trial

The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires, computerized cognitive tests, and have an EEG (a measure of electrical activity in the brain) and functional MRI of brain if possible. Both groups will also complete 2 follow-up surveys (at \~8 weeks, and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults of any race, ethnicity, or gender who are age 25 years or older

Have not had formal mindfulness training

Have not previously used classic psychedelics

Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin plus mindfulness training

    Drug

    Participants will receive a single 25 mg dose of psilocybin under the supervision of study therapists. The psilocybin dosing session will take place approximately halfway through an 8-week mindfulness training course. The mindfulness training course will consist of weekly 2-hour classes with experienced mindfulness teachers; participants will be encouraged to practice mindfulness for 45 minutes per day between classes.

  • Psilocybin

    Drug

    Participants will receive a single 25 mg dose of psilocybin under the supervision of study therapists.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Mindfulness-assisted psilocybin therapyExperimental treatment 1 intervention
Group B: Psilocybin onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Retention at 8-week follow-up

The primary feasibility outcome will be participant retention (percent of eligible enrolled participants who complete the 8-week follow-up session)

Time frame
8-week follow-up
2

Change in stress symptoms

The primary efficacy outcome will be the Short Perceived Stress Scale. This 10-item scale asks participants to rate how frequently they felt certain ways (such as nervous, "stressed", or unable to control important things in their lives) on a scale from 0 (Never) to 4 (Very often). Total scores range from 0-40; higher scores indicate higher levels of perceived stress.

Time frame
8-week follow-up

Secondary outcomes

1

Change in P300 amplitude to self vs. other name

Amplitude of the P300 response to hearing one's own name vs. another stranger's name

Time frame
1 week post psilocybin therapy
2

Change in blood inflammatory markers

V-PLEX Neuroinflammation Panel-1 Human Kit -The ProcartaPlex Human Inflammation Panel 20plex enables the exploration of immune function by analyzing 20 protein targets in a single well using Luminex xMAP technology.

Time frame
acute on same day as psilocybin therapy
3

Number of participants reporting adverse events

The total number of participants reporting adverse events from the time of psilocybin administration through the 8 week follow-up.

Time frame
8-week follow-up
4

Mean severity of adverse events

The mean severity of adverse events reported from the time of psilocybin administration through the 8-week follow-up. Severity of adverse events will be rated using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: 1 = Mild, 2 = Moderate, 3 = Severe; 4 = Life threatening; 5 = Death.

Time frame
8-week follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Source ClinicalTrials.gov
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