Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

This study will investigate whether psilocybin administered under supportive conditions can reduce illicit opioid use and improve quality of life in individuals with Opioid Use Disorder (OUD) in Methadone Maintenance Treatment (MMT) who are concurrently using other opioids illicitly.

Topic Addiction Opioid Use Disorder
Compound Ketamine
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 16 February 2022
End date 01 December 2024
Chance of happening 89%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 92
Sex All
Age 21- 70
Therapy Yes

Trial Details

This randomized double-blind placebo-controlled trial will investigate whether 2 doses of psilocybin administered under supportive conditions can reduce illicit opioid use (assessed by self-report and urine toxicology) and improve quality of life as measured by World Health Organization Quality of Life (WHOQOL-BREF) in individuals with OUD in MMT who are concurrently using other opioids illicitly. In addition, the investigators will investigate secondary outcomes including whether psilocybin under supportive conditions improves mood, reduces use of tobacco and other non-opioid drugs, improves chronic pain and sleep. Ninety-two participants aged 21-70 who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for OUD, are enrolled in a MMT program for at least 3 months, and have urine toxicology positive for methadone and another opioid will be recruited from the community and complete all study procedures. Participants will be randomized to an active group or control group (46 per group). Participants will undergo a total of 2 dosing sessions (whether psilocybin or placebo). The active group will receive 40mg psilocybin first. All participants will receive a second dosing session at three months. The active group will be further randomized, with half receiving 40mg psilocybin, and half receiving placebo at three months to test a secondary hypothesis that two doses of psilocybin are more effective in treating OUD than a single dose.

NCT Number NCT05242029

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.

Papers

Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings
This safety-feasibility trial (n=2) explored the interaction between psilocybin and buprenorphine in adults with opioid use disorder (OUD). The study found that coadministration of psilocybin and buprenorphine was safely tolerated, with no serious adverse events or significant changes in opioid craving or withdrawal measures. Feasibility challenges led to modifications in the study population and eligibility criteria, emphasizing the need for improved accessibility and overall generalizability.

Data attribution

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