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High-dose psilocybin + buprenorphine 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

BIPOD-Out Trial 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.Check my eligibility
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.See study design
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.

BIPOD-Out Trial Eligibility Criteria

Inclusion Criteria

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

BIPOD-Out Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Days Illicit Opioids Used
Number of Negative Urine Toxicologies
Number of Participants Abstinent from Opioid Use
+1 more
Secondary outcome measures
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%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
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

BIPOD-Out 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
~730

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,407 Total Patients Enrolled
Sandeep Nayak, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
90 Total Patients Enrolled

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?

"Information available on clinicaltrials.gov shows that patient enrollment is ongoing for this trial. The study was first listed on 2/8/2024 and most recently revised on 2/19/2024."

Answered by AI

What is the upper limit of participants allowed to take part in this medical study?

"Indeed, information available on clinicaltrials.gov shows that this medical research investigation is actively seeking eligible individuals. The trial was initially published on February 8th, 2024 and most recently revised on February 19th, 2024. Enrollment of approximately 90 participants will take place at a single designated site."

Answered by AI

May individuals younger than 20 years old participate in this research study?

"To be eligible for inclusion in this study, candidates must be at least 21 years old but no older than 70."

Answered by AI

Is it possible for me to participate in this clinical trial?

"This clinical study is currently accepting 90 individuals aged between 21 and 70 who are grappling with opioid use disorder. Essential prerequisites include being proficient in English language skills, readiness to undergo or having already completed buprenorphine induction within the past three weeks, deemed low risk for suicidal tendencies by clinicians on the research team, providing written consent, meeting DSM-5 criteria for OUD diagnosis, abstaining from antidepressants for around five half-lives before enrollment, a history of prior buprenorphine maintenance therapy, testing positive for opioids through urine toxicology screening and ensuring access to secure housing arrangements."

Answered by AI

Has the combination of high-dose psilocybin and buprenorphine received official approval from the FDA?

"Our research team at Power has evaluated the safety of High-dose psilocybin + buprenorphine to be a 2 on our scale. This rating is based on the fact that this trial is in Phase 2, indicating some existing safety data but no evidence yet supporting efficacy."

Answered by AI

What are the specific objectives of this research study?

"The primary aim of this clinical investigation, which will span about 8 weeks, is to assess treatment adherence. Secondary aims involve monitoring the number of participants refraining from other substances apart from those being studied through a combination of TLFB and urine toxicology results; gauging anxiety levels using the State-Trait Anxiety Inventory (STAI), where higher scores indicate more severe mental states like apprehension and worry; and evaluating quality of life with the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) questionnaire, which covers six domains and 24 subdomains reflecting various aspects affecting quality of life on a scale ranging from "

Answered by AI
~60 spots leftby Jul 2025