Status:
RECRUITING
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
Lead Sponsor:
Johns Hopkins University
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
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 bupr...
Detailed Description
The proposed study is a double-blind, controlled investigation of the effect of 1 high-dose psilocybin (30 mg) session compared to a very low dose session (1 mg) in the period immediately following st...
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 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
- 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
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06067737
Start Date
February 8 2024
End Date
May 1 2029
Last Update
July 28 2025
Active Locations (1)
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1
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, United States, 21224