A Phase 2 interventional study of Psilocybin and Psilocybin in Opioid Use Disorder, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 90 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
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Exclusion Criteria:
General medical exclusion criteria:
Psychiatric Exclusion Criteria:
High-dose psilocybin (30 mg) session following standard-of-care outpatient buprenorphine induction
Drug: Psilocybin
Very low dose psilocybin session (1 mg) following standard-of-care outpatient buprenorphine induction
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.
Also known as: buprenorphine
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.
Also known as: buprenorphine
Number of Participants Abstinent from Opioid Use
Non-buprenorphine opioid abstinence as verified by urine toxicology at each visit and Timeline Follow Back (TLFB). These will be combined to assess opioid abstinence for each participant. These will be assessed at the 8-week timepoint for the previous 3-weeks. Missing values will be presumed positive. Timeline Follow Back (TLFB) for Opioids: This is a self-report of drug use per day. This procedure asks participants to retrospectively quantitate their use of drugs. Greater numbers indicate more days using a substance, smaller numbers or zeros mean less or no days using a substance Urine toxicology: Urine samples will be collected at each study visit and screened broadly for illicit drug use including opioids via an outside medical laboratory. Quantitative buprenorphine levels will also be collected following induction to gauge whether buprenorphine is being taken. Participants must meet both criteria to be considered abstinent.
Time frame: Up to 8 weeks
Treatment retention
Treatment retention at 8 weeks, as indicated by participants making all follow-up visits, indicating they are taking buprenorphine and with urine toxicology positive for buprenorphine.
Time frame: 8 weeks
Number of Days Illicit Opioids Used
Number of Days Illicit Opioids Used, as indicated by participant self-report and urine toxicology results
Time frame: 8 weeks
Number of Negative Urine Toxicologies
Number of Negative Urine Toxicologies, as indicated by results from weekly urine toxicologies collected for eight weeks
Time frame: Weekly up to 8 weeks
Quality of Life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) produces a multi-dimensional profile of scores across six domains and 24 sub-domains of quality of life, with higher scores representing a greater reported quality of life. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale.
Time frame: 8 weeks
Depression as assessed by the Beck Depression Inventory II (BDII)
The Beck Depression Inventory is a multi-item assessment for depression. Scores of 0-10 are considered within normal range, with higher scores representing worsening reported depression.
Time frame: 8 weeks
Anxiety as assessed by the State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory is a 40-item assessment of state and trait characteristics, with higher scores (more positive items) representing greater severity of mental states such as apprehension, tension, nervousness, and worry.
Time frame: 8 weeks
Number of Participants Abstinent from Other Drug Substances
Abstinence from other substances will be measured by combining TLFB and urine toxicology results to report the number of participants who were abstinent from other drug substances
Time frame: 8 weeks
Plan to share: No
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