Adjunctive Effects of Psilocybin and Buprenorphine

Brief Summary

Primary Aim: In participants with OUD in early or sustained full recovery on buprenorphine/naloxone therapy, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine/naloxone regimen.

Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of buprenorphine/naloxone maintenance therapy.

Secondary Aim: To evaluate the effect of concurrent buprenorphine/naloxone use on the effects of psilocybin therapy.

Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.

Intervention / Treatment

  • Drug: Psilocybin with guided counseling

Condition or Disease

  • Opioid Use Disorder


Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 21 Years to 65 Years   (Adult, Older Adult)
Enrollment: 10 ()
Funded by: Other


Clinical Trial Dates

Start date: Jan 13, 2021
Primary Completion: Aug 01, 2022
Completion Date: Aug 01, 2022
Study First Posted: Nov 13, 2019
Results First Posted: Aug 30, 2020
Last Updated: Jun 03, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

The primary objective of this clinical trial is to determine the safety of psilocybin in adult patients with opioid use disorder concurrently taking buprenorphine/naloxone (Suboxone®).

Eligible participants will be adults with opioid use disorder (OUD) who have been demonstrated to be stable on a daily buprenorphine/naloxone dose. Recovery status will be verified by the participant's community-based prescriber. After psychological screening and at least 6 hours of preparatory counseling and preparation for the psilocybin dosing, set, and setting, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained guides, in a dedicated Clinical Research Facility. After eight hours of observation in the dosing room, the participant will be kept overnight in the hospital Clinical Research Unit, and complete an integration session with a psychologist before discharge to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation.

Participants who have been administered the first dose but decline to receive the second dose will remain evaluable. At study termination, their active study participation will end, but completion of the 28 day post-dose follow up will be requested.

The primary endpoint is the assessment of the safety of concurrent administration of buprenorphine and naloxone (eg., Suboxone®) and psilocybin as determined by physiological measures (ECG, respiratory rate, blood pressure, body temperature, and blood oxygen saturation) and validated clinical and self-report measures (Clinical Opiate Withdrawal Scale (COWS), Opioid Craving Scale (OCS), Timeline Follow-Back (TLFB)).

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 65

This clinical trial is recruiting

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More Details

NCT Number: NCT04161066
Other IDs: 2019-0187|A532007|SMPH/FAMILY MEDICINE|Protocol Version 9/22/2021
Study URL:
Last updated: Jun 16, 2022