Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

• Status: Suspended
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: All

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 treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Buprenorphine; Psilocybin

Criteria

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.