Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06067737
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    High-dose psilocybin (30 mg) session will be administered following standard-of-care outpatient buprenorphine induction to evaluate its effect on drug abstinence, quality of life, craving, tobacco use, and treatment retention in healthy participants with an active OUD diagnosis.
  • Psilocybin — DRUG
    A very low dose (1 mg) psilocybin session following standard-of-care outpatient buprenorphine induction will be used as a comparator arm to the high-dose psilocybin arm in evaluating psilocybin's effect on drug abstinence, quality of life, craving, tobacco use, and treatment retention in healthy participants with an active OUD diagnosis.

Study Details

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.

Key Dates

Start date
Feb 8, 2024
Status verified
Jul 2025
Primary completion
Jul 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose psilocybin + buprenorphine
    High-dose psilocybin (30 mg) session following standard-of-care outpatient buprenorphine induction
  • Active Comparator: Very low-dose psilocybin + buprenorphine
    Very low dose psilocybin session (1 mg) following standard-of-care outpatient buprenorphine induction

Primary Outcome Measure

Number of Participants Abstinent from Opioid Use [ Time Frame: Up to 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21224
Sandeep Nayak, MD
[email protected]
410-550-2253

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By research site
Johns Hopkins Center for Psychedelic and Consciousness Research· Baltimore, MD

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