NCT06067737 Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
| NCT ID | NCT06067737 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-02-08 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid use disorder (OUD). The participants will have previously undergone buprenorphine induction before. Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with outpatient buprenorphine maintenance, quality of life, and mood.
Eligibility Criteria
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 or has undergone buprenorphine induction in the past 3 weeks * 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.
Contact & Investigator
Sandeep Nayak, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06067737 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06067737 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06067737 currently recruiting?
Yes, NCT06067737 is actively recruiting participants. Contact the research team at gaddis@jhmi.edu for enrollment information.
Where is the NCT06067737 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06067737 clinical trial?
NCT06067737 is sponsored by Johns Hopkins University. The principal investigator is Sandeep Nayak, MD at Johns Hopkins University. The trial plans to enroll 90 participants.