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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
open-label pilot study
University of Wisconsin
Madison, Wisconsin, United States
RECRUITINGSafety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose
In participants with OUD, the safety of this intervention will be assessed by characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine regimen.
Time frame: approximately Week 1
Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose
In participants with OUD, the safety of this intervention will be assessed by characterizing adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone regimen.
Time frame: approximately Week 5
Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument
It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause signs and symptoms of opioid withdrawal. This will be measured by the Clinical Opiate Withdrawal Scale (COWS) instrument, an 11-item scale administered by the clinician where total score of: 5- 12 = mild withdrawal; 13-24 = moderate withdrawal; 25-36 = moderately severe withdrawal; and more than 36 = severe withdrawal. Administered before the dose and again 8 hours after the dose.
Time frame: up to 5 weeks
Mean Change in Peripheral Capillary Oxygen
It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause opioid intoxication. Opioid intoxication will be determined by drops peripheral capillary oxygen saturation (SpO2) before and after dosing.
Time frame: up to 5 weeks
Mean Change in ECG
It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause a clinically significant increase in the QTc interval. The QTc interval will be measured by electrocardiogram (ECG) before and after dosing. If a QTc(F), calculated by the CardioCard system exceeds 470msec, a study physician will be contacted immediately for further monitoring and treatment recommendations.
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Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
10
Time frame: up to 5 weeks
Change in Opioid Craving Scale (OCS) from baseline through end of study
To evaluate the effect of psilocybin treatment on the effectiveness of buprenorphine-naloxone maintenance therapy. The hypothesis is that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause an increase in opioid craving, as measured by the OCS at baseline, week 1, week 5, and week 9. The OCS is a 3-item visual analog scale to measure the frequency and intensity of opioid craving. Total score ranges from 0-30 where the higher the number, the higher the craving.
Time frame: Baseline, Week 1, Week 5, and Week 9
Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB)
It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not be associated with an increase in self-reported illicit opioid use. This will be measured by Time Line Follow-Back calendar method for up to the 28 days following the last dosing session. Participants will be asked to recall the previous 28 days of substance use at the first in-person visit.
Time frame: up to 9 weeks