Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

Description

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

Opioid Use Disorder

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Study Overview

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Study Details

Study overview

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.

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 21-70 years
  • * Have given written informed consent
  • * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD
  • * No antidepressant medications for approximately 5 half-lives prior to enrollment
  • * Willing to undergo buprenorphine induction or has undergone buprenorphine induction in the past 3 weeks
  • * Reports previous buprenorphine maintenance
  • * 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.

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Sandeep Nayak, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-07