Actively Recruiting
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
Led by Johns Hopkins University · Updated on 2025-07-28
90
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 buprenorphine treatment for Opioid use disorder (OUD). The participants will have previously undergone buprenorphine induction before. Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with outpatient buprenorphine maintenance, quality of life, and mood.
CONDITIONS
Official Title
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21-70 years
- Provided written informed consent
- Meet DSM-5 criteria for opioid use disorder
- No antidepressant medications for approximately 5 half-lives before enrollment
- Willing to undergo or have undergone buprenorphine induction in the past 3 weeks
- History of previous buprenorphine maintenance
- Positive urine toxicology for an opioid
- Have access to stable housing
- Can read, write, and speak English fluently
- Judged by study clinicians to be at low risk for suicidality
- Limited recent use of classic psychedelics (no use in the past year)
- Desire sustained recovery from disordered opioid use
You will not qualify if you...
- Women who are pregnant, nursing, or not using effective birth control
- Cardiovascular conditions including hypertension (systolic >139 or diastolic >89), angina, heart rate >99, significant ECG abnormalities, recent transient ischemic attack, stroke, peripheral or pulmonary vascular disease, or cardiac valvulopathy
- Epilepsy
- Insulin-dependent diabetes or history of hypoglycemia if taking oral hypoglycemics
- Daily use of medications affecting serotonin such as serotonin-reuptake inhibitors or MAO inhibitors
- Use of certain medications including efavirenz, disulfiram, alcohol dehydrogenase inhibitors, or specific enzyme inhibitors
- Currently taking methadone or naltrexone
- Longstanding buprenorphine maintenance (more than 3 weeks post-induction)
- Naïve to buprenorphine
- History of severe withdrawal, medical complications, or hospitalization during previous buprenorphine inductions
- Unable or unwilling to stop acid-reducing agents or major enzyme inhibitors prior to dosing
- History of seizure disorder, multiple sclerosis, significant head trauma, CNS tumor, movement disorders, or neurodegenerative conditions
- Morbid obesity (over 100 lbs above ideal body weight, BMI ≥40, or BMI ≥35 with high blood pressure or diabetes)
- Body weight less than 45 kg
- Judged at risk for moderate or severe alcohol or benzodiazepine withdrawal
- Allergy to buprenorphine
- Blood test abnormalities including elevated transaminases, low hemoglobin, or low creatinine clearance
- Current or past history of schizophrenia, psychotic disorders, bipolar I or II disorder, or major depression with psychotic features
- First or second degree relative with schizophrenia, psychotic disorder, or bipolar I or II disorder
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
A
Andrew L Gaddis, MD
CONTACT
S
Sandeep Nayak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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