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Psychedelic Therapy

Mindfulness-assisted psilocybin therapy for Mental Health (MAPT Trial)

Phase 2

Waitlist Available

Led By Baruch R Cahn, MD, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-week follow-up

Awards & highlights

MAPT Trial Summary

This trial is testing the effects of combining psilocybin (a psychedelic drug) with mindfulness training on mental health in healthy adults. Participants will be randomly assigned to either receive one dose of psiloc

Who is the study for?

This trial is for healthy adults interested in exploring the effects of psychedelic therapy on mental health. Participants must be eligible based on an initial session and willing to undergo psilocybin treatment under supervision, with or without mindfulness training. Details about specific inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The study tests if mindfulness training can boost the benefits of psilocybin, a psychedelic drug, for mental health. Participants will either receive psilocybin with 8 weeks of mindfulness classes (Arm 1) or just psilocybin (Arm 2), followed by assessments including questionnaires and EEGs.See study design

What are the potential side effects?

Potential side effects may include changes in mood, perception, cognition due to psilocybin use; however, specifics aren't detailed here. Mindfulness training typically does not have physical side effects but could affect emotional state.

MAPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in anxiety symptoms

Change in depression symptoms

Change in stress symptoms

Secondary outcome measures

Change in P300 amplitude to self vs. other name

Change in blood inflammatory markers

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Fungal infection

Pyrexia

Hypoesthesia

Oedema

Vomiting

Rhinorrhea

Musculoskeletal pain

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

MAPT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-assisted psilocybin therapyExperimental Treatment1 Intervention

8 weeks of mindfulness training plus one 25mg dose of psilocybin

Group II: Psilocybin onlyActive Control1 Intervention

One 25mg dose of psilocybin

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,238 Total Patients Enrolled

2 Trials studying Mental Health

635 Patients Enrolled for Mental Health

Baruch R Cahn, MD, PhDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"Based on the information available on clinicaltrials.gov, this particular trial is no longer seeking participants. Its initial posting was on July 1st, 2024 and it was last edited on January 22nd, 2024. However, there are currently 58 other ongoing clinical trials that are actively enrolling patients at this time."

Answered by AI

What are the potential risks associated with utilizing mindfulness as a tool in psilocybin therapy for individuals?

"Based on the assessment of our team at Power, Mindfulness-assisted psilocybin therapy has been assigned a safety rating of 2 on a scale from 1 to 3. This designation reflects that while there is some existing data supporting its safety, no evidence regarding efficacy has been established yet due to it being in Phase 2 trial stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mindfulness-assisted Psychedelic Therapy

Rael Cahn 2024. "Mindfulness-assisted Psychedelic Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06233344.