Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psilocybin with facilitated counseling.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on a Buprenorphine/Naloxone Formulation
Overview
Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a 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.
Detailed description
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.
Eligible participants will be adults with active opioid use disorder (OUD) who are willing to begin and maintain a daily dose of buprenorphine-naloxone throughout study participation. Initiation, stabilization, and maintenance of buprenorphine-naloxone will be overseen by a qualified study medical provider. 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 facilitators, 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 a buprenorphine-naloxone formulation 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)).
If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the "More Information" section at the bottom of this record.
Interventions
- Drug Psilocybin with facilitated counseling
open-label pilot study
Primary outcome measures
- Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [Time frame: approximately Week 1]
- Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [Time frame: approximately Week 5]
- Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument [Time frame: up to 5 weeks]
- Mean Change in Peripheral Capillary Oxygen [Time frame: up to 5 weeks]
- Mean Change in ECG [Time frame: up to 5 weeks]
Secondary outcome measures (2)
- Change in Opioid Craving Scale (OCS) from baseline through end of study [Time frame: Baseline, Week 1, Week 5, and Week 9]
- Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB) [Time frame: up to 9 weeks]
Eligibility criteria
Inclusion criteria
- Aged 21 to 65 years
- Able to read, speak, and understand spoken and written English
- Diagnosis of moderate or severe opioid use disorder (OUD)
- Current opioid misuse, with misuse occurring on at least 10 of the last 30 days (at least 5 of last 30 days if already on buprenorphine/naloxene. See exclusion #1). Misuse will be defined as either:
- Use of illicit opioids, such as heroin or street fentanyl; or use of a prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route (e.g. nasal, injected) other than FDA approved , and/or
- Use of a prescription opioid for a purpose (e.g. intoxication, anxiety relief) other than that for which it was prescribed.
- Able to achieve stable daily dose of a buprenorphine-naloxone formulation that controls opioid withdrawal symptoms
- Persons of childbearing potential must agree to practice an effective means of contraception throughout their participation in the study, beginning at screening and throughout follow-up
- Ability and willingness to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and evaluations
- Healthy kidney function
- Able to provide contact information for a local support person. This person must be available during both 24-hour treatment and observation periods, and willing to provide the participant social/emotional support the day after each treatment and as needed during the dosing day and/or overnight observation period.
Exclusion criteria
- Currently prescribed and has taken buprenorphine or buprenorphine formulation (e.g., Suboxone®) for over four months immediately prior to initial study contact
- Currently receiving pharmacotherapy of any duration with methadone
- Current participation in a drug treatment court program or other legal supervision. Individuals who are under legal supervision will be advised that participating in this study could potentially violate terms of probation, parole, or extended supervision. Contact information for the individual's community supervision officer must be collected to confirm whether study participation may impact the potential participant's status on probation or parole
- Inadequately treated hypertension
- Current acute coronary syndrome or angina
- Evidence of ischemic disease, cardiac conduction defects, and/or ventricular arrhythmias on screening ECG
- History of heart transplant
- Current insulin dependence, due to Type I or Type II diabetes
- Urine drug test containing non-prescribed drugs of abuse
- Any finding(s), based on the screening process, that the PI feels makes the study unsuitable for the participant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT04161066 · 2019-0187 · A532007 · SMPH/FAMILY MEDICINE · Protocol Version 02/17/2025