Status:
SUSPENDED
Inpatient 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 buprenorphine t...
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) following standard-of-care buprenorphi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06005662
Start Date
April 1 2027
End Date
July 1 2028
Last Update
February 6 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21224