Adjunctive Effects of Psilocybin and Buprenorphine

Primary Aim: In participants with opioid use disorder (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.

Topic Addiction Opioid Use Disorder
Compound Psilocybin
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 13 January 2021
End date 01 August 2022
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 10
Sex All
Age 21- 65
Therapy No

Trial Details

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)).

NCT Number NCT04161066

Sponsors & Collaborators

University of Zurich
Within the Department of Psychiatry, Psychotherapy and Psychosomatics at the University of Zurich, Dr Mialn Scheidegger is leading team conducting psychedelic research and therapy development.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.