Psilocybin opioid study pulled before it began
NCT ID NCT06005662
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if adding a single high dose of psilocybin (30 mg) to standard buprenorphine treatment could help people with opioid use disorder stay off illicit opioids and improve their quality of life. It planned to enroll adults aged 21–70 who were not already on opioid medications. However, the study was withdrawn before enrolling any participants, so no results are available.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
Apr 2027
An estimate. Start dates often move.
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
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
-
21 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
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 criteria for OUD * No antidepressant medications for approximately 5 half-lives prior to enrollment * Not currently taking methadone, buprenorphine or naltrexone * 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 electrocardiogram abnormality (e.g., atrial fibrillation), Transient Ischemic Attack or Stroke in the last 6 months, 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 inhibitors. o For individuals who have intermittent or as needed 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 medicines such as phenytoin, regorafenib, eltrombopag. * Currently taking buprenorphine, methadone, or naltrexone. * 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, nervous system tumor, movement disorders or any neurodegenerative condition. * Morbidly obese (\>100 pounds above ideal body weight, or Body Mass Index (BMI) \>=40, or BMI \>=35 with high blood pressure or diabetes) * Body weight \< 45 kilograms * Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal. * Allergic to buprenorphine or hydromorphone * 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. Psychiatric Exclusion Criteria: * Current or past history of meeting diagnostic 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Opioid-use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Johns Hopkins University
Baltimore, Maryland, 21224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise boost brain and body health during opioid treatment?
- Can a new drug calm the storm of opioid withdrawal?
- Can coaching turn rural clinics into One-Stop shops for addiction and infectious disease care?
- Can a Phone-Based platform keep people in opioid treatment?
- A safety net after jail: can checkups keep opioid treatment on track?
- Can AI and peer support close the opioid treatment gap?