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Psilocybin for Opioid Use Disorder (BIPOD-In Trial)

Phase 2

Waitlist Available

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

Not currently taking methadone, buprenorphine or naltrexone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

BIPOD-In Trial Summary

This trial will study if a single, high dose of psilocybin can help opioid users reduce usage and improve quality of life.

Who is the study for?

This trial is for adults aged 21-70 with Opioid Use Disorder who are not on methadone, buprenorphine, or naltrexone. Participants must have a positive opioid test, stable housing, and be off antidepressants for a certain period. They should understand English well and not have used psychedelics recently.Check my eligibility

What is being tested?

The study tests high-dose psilocybin therapy (30 mg) against a very low dose (1 mg) alongside standard buprenorphine treatment for opioid addiction. It aims to see how psilocybin affects abstinence from opioids, adherence to treatment, life quality, and mood over time.See study design

What are the potential side effects?

Psilocybin may cause psychological effects like altered perception of reality or mood changes. Physical side effects can include nausea or headaches. The risk of serious adverse events is considered low but will be monitored closely.

BIPOD-In Trial 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.

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I am not currently using methadone, buprenorphine, or naltrexone.

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I have been diagnosed with opioid use disorder.

BIPOD-In Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Opioid Abstinence

+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

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

BIPOD-In 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 buprenorphine induction

Group II: Very low-dose psilocybin + buprenorphineActive Control1 Intervention

Very low dose psilocybin session (1 mg) following standard-of-care buprenorphine induction

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~730

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,819,981 Total Patients Enrolled

Sandeep Nayak, MDPrincipal InvestigatorJohns Hopkins School of Medicine

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.

What is the total number of participants this clinical trial can accommodate?

"Yes, as per clinicaltrials.gov's records, this medical experiment is in the midst of recruiting participants. It was first advertised on November 1st 2023 and has since been updated on November 28th 2023; 90 patients are needed at a single site."

Answered by AI

Is the enrollment for this medical examination limited to people over a certain age?

"Patients between 21 and 70 years old can participate in this clinical trial, with 88 studies available for those below the legal age of consent, and 395 if they are above 65."

Answered by AI

Is this research project actively seeking participants?

"Affirmative, data from clinicaltrials.gov suggests that the trial is currently recruiting patients who meet the eligibility criteria. This investigation was originally posted on November 1st 2023 and recently updated on November 28th 2023; 90 participants are needed for this single-site study."

Answered by AI

What are the desired outcomes of this clinical trial?

"The purpose of this short-term clinical trial is to examine the Number of Negative Urine Toxicologies over an 8 week period. In addition, secondary objectives involve assessing Depression using the Beck Depression Inventory II (BDII), Quality of Life with World Health Organization Quality of Life-BREF (WHOQOL-BREF) and Anxiety by means of State-Trait Anxiety Inventory (STAI)."

Answered by AI

To what extent is there potential for harm with the concurrent use of high-dose psilocybin and buprenorphine?

"Although this is a Phase 2 trial, meaning data exists to suggest safety but not efficacy, our team at Power assesses the security of high-dose psilocybin + buprenorphine as a 2 on a 1-3 scale."

Answered by AI

To whom is this research opportunity available?

"This medical experiment is recruiting 90 individuals between the ages of 21 and 70 who have opioid use disorder. To qualify, applicants must meet pre-specified conditions such as having provided written informed consent; meeting criteria for OUD diagnosis; not taking antidepressant drugs in the past 5 half lives prior to enrollment; abstaining from methadone, buprenorphine or naltrexone; testing positive for opioids via toxicology screening; being able to access stable housing and read/speak English fluently etc., with limited recent psychedelic drug usage (no use within a year)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

2024. "Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005662.

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