RECRUITING

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

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Conditions

Opioid Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-08
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06067737

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.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21-70 years
  2. * Have given written informed consent
  3. * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD
  4. * No antidepressant medications for approximately 5 half-lives prior to enrollment
  5. * Willing to undergo buprenorphine induction or has undergone buprenorphine induction in the past 3 weeks
  6. * Reports previous buprenorphine maintenance
  7. * Urine toxicology positive for an opioid
  8. * Has access to stable housing
  9. * Can read, write, and speak English fluently
  10. * Be judged by study team clinicians to be at low risk for suicidality
  11. * Have limited recent use of classic psychedelics (no use in the past year).
  12. * Expresses a desire for sustained recovery from disordered opioid use.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Andrew L Gaddis, MD
CONTACT
410-550-0048
gaddis@jhmi.edu
Sandeep Nayak, MD
CONTACT
410-550-0048
smn@jhmi.edu

Principal Investigator

Sandeep Nayak, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Sandeep Nayak, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-08
Study Completion Date2025-07

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder