Clinical TrialOpioid Use Disorder (OUD)PsilocybinPsilocybinWithdrawn

Inpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder (BIPOD-In)

Double-blind, controlled trial (n=90) comparing a single high-dose psilocybin session (30 mg) versus a very low dose (1 mg) as adjunctive therapy to standard buprenorphine treatment for OUD.

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

Detailed Description

Randomised, quadruple-blind, parallel-group trial enrolling up to 90 participants with opioid use disorder undergoing standard buprenorphine induction; participants receive either 30 mg or 1 mg oral psilocybin during a brief inpatient admission.

Primary outcome is opioid abstinence at 8 weeks; additional outcomes include buprenorphine adherence, quality of life, craving, tobacco use, and retention. The design uses Bayesian sequential monitoring with planned interim analyses to allow early stopping for efficacy or futility.

Study includes a 6-8 day inpatient induction and dosing phase with preparatory sessions (2-3), followed by an 8-week outpatient maintenance and longer-term follow-up to 4 months.

Study Protocol

Preparation

3 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 buprenorphine induction.

Interventions

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

    Adjunctive to open-label buprenorphine induction/maintenance.

Very low-dose psilocybin

active comparator

Very low-dose psilocybin (1 mg) session following buprenorphine induction (active comparator).

Interventions

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

    Very low dose active comparator; buprenorphine procedures open-label and per standard of care.

Participants

Ages
21 – 70
Sexes
Male & Female

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

  • Women who are pregnant, nursing, or not practising an effective means of birth control
  • Cardiovascular conditions: hypertension with resting blood pressure systolic >139 or diastolic >89, angina, heart rate >99, clinically significant ECG abnormality (e.g., atrial fibrillation), TIA or stroke in last 6 months, peripheral or pulmonary vascular disease, cardiac valvulopathy
  • Epilepsy
  • Insulin-dependent diabetes; if taking oral hypoglycaemic agent, then no history of hypoglycaemia
  • Currently taking on a daily basis any medications (including herbal substances and supplements) with a central nervous system effect on serotonin, including SSRIs and MAOIs (intermittent use requires 5 half-lives washout)
  • Currently taking efavirenz, disulfiram or similar, 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 dosing
  • Seizure disorder, multiple sclerosis, history of significant head trauma, nervous system tumour, movement disorders or neurodegenerative condition
  • Morbidly obese (>100 pounds above ideal body weight, or BMI >=40, or BMI >=35 with high blood pressure or diabetes)
  • Body weight <45 kilograms
  • At risk for moderate or severe alcohol or benzodiazepine withdrawal
  • Allergic to buprenorphine or hydromorphone
  • Exclusionary labs: transaminases >2x ULN, hemoglobin <11 g/dL, creatinine clearance <40 ml/min
  • Psychiatric: current or past schizophrenia, psychotic disorder (unless substance-induced or due to a medical condition), Bipolar I/II, or major depression with psychotic features
  • First- or second-degree relative with schizophrenia, psychotic disorder (unless substance-induced or due to a medical condition), or bipolar I/II disorder

Study Details

Locations

Johns Hopkins University — Baltimore, Maryland, United States

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