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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
Johns Hopkins Center for Psychedelic and Consciousness Research
RECRUITING
Baltimore
Contact Information
Primary
Andrew L Gaddis, MD
gaddis@jhmi.edu
410-550-0048
Backup
Sandeep Nayak, MD
smn@jhmi.edu
410-550-0048
Time Frame
Start Date: 2024-02-08
Estimated Completion Date: 2029-05
Participants
Target number of participants: 90
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov