Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

This study is testing if adding psilocybin (a psychedelic drug) to standard buprenorphine treatment can help people with Opioid Use Disorder (OUD). You would receive either a high dose (30 mg) or a very low dose (1 mg) of psilocybin after starting buprenorphine. Researchers want to see if psilocybin helps with staying off opioids, improving quality of life, reducing cravings, and staying in treatment. To join, you need to be between 21 and 70 years old, have an OUD diagnosis, and be willing to start or already be on buprenorphine. The study aims to enroll 90 participants, but its current status is unclear.

Study design: This is a double-blind, controlled study comparing a high dose of psilocybin to a very low dose. It plans to enroll 90 participants.
What's involved: You would undergo buprenorphine induction, followed by a single psilocybin session. The study will then track your progress for up to 8 weeks.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for outcomes like opioid abstinence and treatment retention for up to 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

Recruiting

PHASE2Ages 21–70InterventionalTreatment

Johns Hopkins University

~90 participants

Updated 2026-07-17 on ClinicalTrials.gov

What's tested:Psilocybin

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of Participants Abstinent from Opioid Use

Measured over Up to 8 weeks

+3 more outcomes measured

Conditions

Opioid Use Disorder

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Sandeep Nayak, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Andrew L Gaddis, MD

[email protected]

410-550-0048

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Age 21-70 years

Have given written informed consent

Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD

No antidepressant medications for approximately 5 half-lives prior to enrollment

Willing to undergo buprenorphine induction, has undergone buprenorphine induction in the past 3 weeks, or are in buprenorphine treatment with ongoing use of other opioids (evidenced by positive urine toxicology for buprenorphine and another opioid at time of screen)

Reports previous buprenorphine maintenance

Urine toxicology positive for an opioid

Has access to stable housing

Can read, write, and speak English fluently

Be judged by study team clinicians to be at low risk for suicidality

Have limited recent use of classic psychedelics (no use in the past year).

Expresses a desire for sustained recovery from disordered opioid use.

Exclusion

Women who are pregnant, nursing, or not practicing an effective means of birth control

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

Epilepsy

Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia

Currently taking on a daily basis any medications (including herbal substances and supplements) with a central nervous system effect on serotonin, including serotonin-reuptake inhibitors and monoamine oxidase (MAO) inhibitors.

For individuals who have intermittent or as needed (PRN) use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.

Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UDP-glucuronosyltransferase (UGT)1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.

Currently taking methadone or naltrexone.

Currently on longstanding buprenorphine maintenance (3+ weeks post-induction)

Naïve to buprenorphine

Reports of significant adverse events (severe withdrawal, medical complications, hospitalization) during previous buprenorphine induction(s).

Unable or unwilling to discontinue acid-reducing agents or major metabolizing enzyme inhibitors for 5-half lives prior to the experimental dosing session.

Have a seizure disorder, multiple sclerosis, history of significant head trauma, central nervous system (CNS) tumor, movement disorders or any neurodegenerative condition.

Morbidly obese (\>100 lbs above ideal body weight, or Body Mass Index (BMI) \>=40, or BMI \>=35 with high blood pressure or diabetes)

Body weight \< 45 kg

Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal.

Allergic to buprenorphine

For blood samples, the following lab values will be exclusionary: transaminases greater than x2 the upper limit of normal lab reference range, hemoglobin less than 11 g/d, and creatinine clearance \< 40 ml/min using the Cockraft and Gault equation.

Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), Bipolar I or II Disorder or Major Depression with psychotic features.

Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.

What this trial measures

Number of Participants Abstinent from Opioid UseUp to 8 weeks
Non-buprenorphine opioid abstinence as verified by urine toxicology at each visit and Timeline Follow Back (TLFB). These will be combined to assess opioid abstinence for each participant. These will be assessed at the 8-week timepoint for the previous 3-weeks. Missing values will be presumed positive. Timeline Follow Back (TLFB) for Opioids: This is a self-report of drug use per day. This procedure asks participants to retrospectively quantitate their use of drugs. Greater numbers indicate more days using a substance, smaller numbers or zeros mean less or no days using a substance Urine toxicology: Urine samples will be collected at each study visit and screened broadly for illicit drug use including opioids via an outside medical laboratory. Quantitative buprenorphine levels will also be collected following induction to gauge whether buprenorphine is being taken. Participants must meet both criteria to be considered abstinent.
Treatment retention8 weeks
Treatment retention at 8 weeks, as indicated by participants making all follow-up visits, indicating they are taking buprenorphine and with urine toxicology positive for buprenorphine.
Number of Days Illicit Opioids Used8 weeks
Number of Days Illicit Opioids Used, as indicated by participant self-report and urine toxicology results
Number of Negative Urine ToxicologiesWeekly up to 8 weeks
Number of Negative Urine Toxicologies, as indicated by results from weekly urine toxicologies collected for eight weeks

Trialytics