Clinical TrialOpioid Use Disorder (OUD)PsilocybinPsilocybinRecruiting

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

This double-blind, controlled trial (n=90) aims to investigate the effect of a single high dose of psilocybin therapy (30mg) versus a very low dose (1mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid Use Disorder (OUD).

Target Enrollment
90 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, double-blind, parallel-group trial comparing a single 30 mg oral psilocybin session to a 1 mg very low-dose session administered after outpatient buprenorphine induction in adults with OUD (n=90).

Participants receive 2–4 preparatory sessions, an open-label buprenorphine maintenance phase, and follow-up visits at 1, 2, 3, 4, 6 and 8 weeks post-dosing to assess opioid abstinence, treatment retention, quality of life, craving, tobacco use, and safety.

Study Protocol

Preparation

4 sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

High-dose psilocybin

experimental

Single high-dose psilocybin (30 mg) session following outpatient buprenorphine induction.

Interventions

  • Psilocybin30 mg
    via Oral• single dose• 1 doses total

    Administered after standard-of-care outpatient buprenorphine induction; preparatory sessions precede dosing.

Very low-dose psilocybin

active comparator

Single very low-dose psilocybin (1 mg) session following outpatient buprenorphine induction (active comparator).

Interventions

  • Psilocybin1 mg
    via Oral• single dose• 1 doses total

    Very low dose comparator; administered after buprenorphine induction.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Age 21-70 years\n* Have given written informed consent\n* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for OUD\n* No antidepressant medications for approximately 5 half-lives prior to enrollment\n* Willing to undergo buprenorphine induction or has undergone buprenorphine induction in the past 3 weeks\n* Reports previous buprenorphine maintenance\n* Urine toxicology positive for an opioid\n* Has access to stable housing\n* Can read, write, and speak English fluently\n* Be judged by study team clinicians to be at low risk for suicidality\n* Have limited recent use of classic psychedelics (no use in the past year)\n* Expresses a desire for sustained recovery from disordered opioid use.

Exclusion Criteria

  • Exclusion Criteria:\n\nGeneral medical exclusion criteria:\n\n* Women who are pregnant, nursing, or not practicing an effective means of birth control\n* 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\n* Epilepsy\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Currently taking daily medications with a central nervous system effect on serotonin, including SSRIs and MAO inhibitors; for intermittent/PRN use, psilocybin sessions will not be conducted until at least 5 half-lives have elapsed after the last dose\n* Currently taking efavirenz, disulfiram, alcohol dehydrogenase inhibitors, or UGT1A9/1A10 inhibitors such as phenytoin, regorafenib, eltrombopag\n* Currently taking methadone or naltrexone\n* Currently on longstanding buprenorphine maintenance (>=3 weeks post-induction)\n* Naïve to buprenorphine\n* Reports of significant adverse events (severe withdrawal, medical complications, hospitalization) during previous buprenorphine induction(s)\n* Unable or unwilling to discontinue acid-reducing agents or major metabolizing enzyme inhibitors for 5 half-lives prior to the experimental dosing session\n* Have a seizure disorder, multiple sclerosis, history of significant head trauma, central nervous system (CNS) tumor, movement disorders or any neurodegenerative condition\n* Morbidly obese (>100 lbs above ideal body weight, or BMI >=40, or BMI >=35 with high blood pressure or diabetes)\n* Body weight <45 kg\n* Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal\n* Allergic to buprenorphine\n* For blood samples, the following lab values will be exclusionary: transaminases greater than 2x the upper limit of normal lab reference range, hemoglobin less than 11 g/dL, and creatinine clearance <40 ml/min using the Cockcroft and Gault equation.\n\nPsychiatric Exclusion Criteria:\n\n* 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\n* 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.

Study Details

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States

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