Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

This double-blind, controlled trial (n=90) aims to investigate the effect of a single high dose of psilocybin therapy (30mg) versus a very low dose (1mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid Use Disorder (OUD).

Conducted by Johns Hopkins University, this study targets healthy participants aged 21-70 years who meet DSM-5 criteria for OUD and have a history of buprenorphine prescription. Participants must have undergone buprenorphine induction in the past 3 weeks or be interested in undergoing it.

The trial will evaluate the effects of psilocybin on opioid abstinence, treatment adherence, quality of life, mood, and craving over an 8-week period following induction.

The primary outcome measures include the number of participants abstinent from opioids, treatment retention, number of days of illicit opioid use, and number of negative urine toxicologies. Secondary outcome measures include quality of life, depression, anxiety, and abstinence from other drug substances. The study began on February 8, 2024, and is expected to be completed by July 2025.

Topic Opioid Use Disorder Addiction
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 08 February 2024
End date 31 July 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 90
Sex All
Age 21- 70
Therapy Yes

Trial 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.

NCT Number NCT06067737

Sponsors & Collaborators

Johns Hopkins University
Johns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.

Data attribution

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