NCT06067737

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study is a double-blind, controlled investigation of the effect of 1 high-dose psilocybin (30 mg) session compared to a very low dose session (1 mg) in the period immediately following standard-of-care outpatient buprenorphine induction on drug abstinence, quality of life, craving, tobacco use, and treatment retention in healthy participants with an active OUD diagnosis and a history of being prescribed buprenorphine previously. Use of buprenorphine is standard of care for OUD, and the investigators are investigating the additive power of adjunctive psilocybin to enhance opioid abstinence, treatment adherence, quality of life, and mood. Of note, this trial is designed with a parallel and complementary structure to IRB00344281 (BIPOD: Buprenorphine Induction with Psilocybin for Opioid use Disorder: A Randomized Controlled Clinical Trial"). The current proposed trial ("BIPOD-Out") differs in that it is tailored specifically to identify participants who have previously been prescribed and tolerated buprenorphine but subsequently relapsed. The study will recruit participants who have very recently (past 3 weeks) undergone standard of care outpatient buprenorphine induction or are interested in undergoing buprenorphine induction by a study team physician and offer experimental psilocybin administration, as utilized in several other studies at this center. As noted above (and unlike in IRB00344281), participants naïve to buprenorphine will be excluded from this study. Outpatient buprenorphine induction will be followed by an 8-week outpatient phase involving standard of care buprenorphine maintenance with participants referred to further buprenorphine treatment in the community and followed in long-term follow-up for 4 to 6 months. The study team will recruit participants who have recently (past 3 weeks) been inducted onto sublingual (SL) buprenorphine (a buprenorphine/naloxone combination product) in the outpatient setting, and also participants interested in participating in a buprenorphine induction conducted by one of the study team physicians. Once buprenorphine induction is complete and participants are deemed eligible, participants will undergo 2-4 preparatory sessions (described below), followed by an experimental drug administration session under supportive conditions, during which the participants will receive either a very low dose (1 mg) or a single high (30mg) oral dose of psilocybin under double-blind conditions. Participants will then complete an 8-week outpatient phase, during which a study team clinician will provide standard of care outpatient buprenorphine maintenance. Participants will undergo outpatient visits at 1, 2, 3, 4, 6, and 8 weeks post-dosing session at the Behavioral Pharmacology Research Unit for monitoring of adverse events, clinical status, treatment adherence, and to receive a weekly supply of buprenorphine. All buprenorphine procedures will be open label and will follow standard-of-care practices.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	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.
DRUG	Psilocybin	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.

Timeline

• Start date: 2024-02-08
• Primary completion: 2028-07-01
• Completion: 2029-05-01
• First posted: 2023-10-05
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study