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Psilocybin for Opioid Use Disorder (BIPOD-Out Trial)

Phase 2
Recruiting
Led By Sandeep Nayak, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-70 years
Be older than 18 years old
Must not have
Cardiovascular conditions: hypertension with resting blood pressure systolic >139 or diastolic >89, angina, heart rate > 99, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc > 450), transient ischemic attack (TIA) in the last 6 months, stroke, peripheral or pulmonary vascular disease, cardiac valvulopathy
Naïve to buprenorphine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at the impact of a high dose (30 mg) and a very low dose (1 mg) of psilocybin therapy in addition to standard buprenorphine treatment

Who is the study for?
This trial is for adults aged 21-70 with Opioid Use Disorder who are fluent in English, willing to undergo or have recently completed buprenorphine induction, and not at high risk for suicide. Participants must meet DSM-5 criteria for OUD, be off antidepressants for a certain period, have prior buprenorphine maintenance experience, test positive for opioids in urine tests, and have stable housing.
What is being tested?
The study is testing the effects of a single high dose (30 mg) versus a very low dose (1 mg) of psilocybin therapy as an add-on to standard outpatient buprenorphine treatment. It aims to see how psilocybin affects opioid abstinence rates, adherence to buprenorphine maintenance programs, quality of life improvements, and mood changes over time.
What are the potential side effects?
While specific side effects are not listed here, psilocybin can typically cause sensory alterations like visual changes or hallucinations; emotional shifts such as euphoria or introspection; cognitive impacts including altered sense of time; and physical reactions like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart or blood vessel problems, like high blood pressure, chest pain, or a recent stroke.
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I have never taken buprenorphine.
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I cannot or will not stop taking acid-reducing drugs or certain other medications before the trial.
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A close family member has schizophrenia, bipolar disorder, or a psychotic disorder.
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I have epilepsy.
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I've had severe reactions to buprenorphine treatment before.
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I have diabetes and use insulin without experiencing low blood sugar.
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I am currently on methadone or naltrexone.
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I am currently taking medication that affects serotonin in my brain.
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I am significantly overweight with a BMI of 35 or more, possibly with high blood pressure or diabetes.
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My body weight is less than 45 kg.
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I have a neurological condition like seizures, MS, or a brain injury.
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I am currently taking medications like efavirenz or disulfiram.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Days Illicit Opioids Used
Number of Negative Urine Toxicologies
Number of Participants Abstinent from Opioid Use
+1 more
Secondary study objectives
Anxiety as assessed by the State-Trait Anxiety Inventory (STAI)
Depression as assessed by the Beck Depression Inventory II (BDII)
Number of Participants Abstinent from Other Drug Substances
+1 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-dose psilocybin + buprenorphineExperimental Treatment1 Intervention
High-dose psilocybin (30 mg) session following standard-of-care outpatient buprenorphine induction
Group II: Very low-dose psilocybin + buprenorphineActive Control1 Intervention
Very low dose psilocybin session (1 mg) following standard-of-care outpatient buprenorphine induction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,720 Total Patients Enrolled
Sandeep Nayak, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
110 Total Patients Enrolled
~39 spots leftby Jul 2025
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