Clinical trial NCT04161066: Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Opioid Use Disorder
Keywords: Psilocybin
Buprenorphine
Naloxone
Buprenorphine-Naloxone
Psilocybin-Assisted Therapy
Opioid
Substance Use Disorder
Psychedelic
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Heffter Research Institute
name: Etheridge Foundation
First posted: 2019-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label pilot study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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. Misuse will be defined as either:

  1. Use of illicit opioids, such as heroin or non-prescribed fentanyl; or use of an outpatient prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route other than FDA approved (e.g. nasal, injected), and/or
  2. Use of a prescription opioid via a route (e.g. nasal, injected, chewed) or 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 weeks 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

Primary outcomes:
measure: Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose
timeFrame: approximately Week 1
measure: Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose
timeFrame: approximately Week 5
measure: Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument
timeFrame: up to 5 weeks
measure: Mean Change in Peripheral Capillary Oxygen
timeFrame: up to 5 weeks
measure: Mean Change in ECG
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Change in Opioid Craving Scale (OCS) from baseline through end of study
timeFrame: Baseline, Week 1, Week 5, and Week 9
measure: Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB)
timeFrame: up to 9 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Randall Brown, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: