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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
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 • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Influenza
4%
Oropharyngeal pain
4%
Insomnia
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Pyrexia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Fungal infection
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Restlessness
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
915 Previous Clinical Trials
1,603,684 Total Patients Enrolled
2 Trials studying Mental Health
635 Patients Enrolled for Mental Health
Baruch R Cahn, MD, PhDPrincipal InvestigatorUniversity of Southern California
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