Psilocybin for Opioid Use Disorder
(BIPOD-In Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySandeep Nayak, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins University

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

Eligibility Criteria

This trial is for adults aged 21-70 with Opioid Use Disorder who are not on methadone, buprenorphine, or naltrexone. Participants must have a positive opioid test, stable housing, and be off antidepressants for a certain period. They should understand English well and not have used psychedelics recently.

Inclusion Criteria

You have access to a reliable dwelling.

I haven't taken antidepressants for their full withdrawal period before joining.

A toxicological analysis of your urine showed the presence of an opioid.

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Treatment Details

Interventions

Psilocybin (Psychedelic Therapy)

Trial OverviewThe study tests high-dose psilocybin therapy (30 mg) against a very low dose (1 mg) alongside standard buprenorphine treatment for opioid addiction. It aims to see how psilocybin affects abstinence from opioids, adherence to treatment, life quality, and mood over time.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: High-dose psilocybin + buprenorphineExperimental Treatment1 Intervention

High-dose psilocybin (30 mg) session following standard-of-care buprenorphine induction

Group II: Very low-dose psilocybin + buprenorphineActive Control1 Intervention

Very low dose psilocybin session (1 mg) following standard-of-care buprenorphine induction