Could a single dose of psilocybin help people break free from opioid addiction?
NCT ID NCT06067737
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study tests whether a single high dose of psilocybin (the active ingredient in magic mushrooms) can help people with opioid use disorder stay off illicit opioids when added to standard buprenorphine treatment. About 90 adults who have already started buprenorphine will receive either a high dose (30 mg) or a very low dose (1 mg) of psilocybin in a controlled setting. Researchers will track opioid abstinence, treatment retention, and quality of life over 8 weeks to see if psilocybin provides an extra benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a single high dose (30 mg) of psilocybin, compared to a very low dose (1 mg), given alongside standard buprenorphine treatment
- What this could lead to
- If it works, this could point toward a new way to boost the effectiveness of standard opioid-use-disorder treatment, helping more people stay off illicit opioids and improve their quality of life.
- What could go wrong
- This is a mid-stage trial with only 90 participants, so results may not apply to everyone. The high dose of psilocybin can cause intense psychological effects, and it is unknown whether any benefit will last beyond the 8-week follow-up.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: General medical exclusion criteria: * 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. Psychiatric Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Center for Psychedelic and Consciousness Research
RECRUITINGBaltimore, Maryland, 21224, United States
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