Adjunctive Effects of Psilocybin and Buprenorphine
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|ClinicalTrials.gov Identifier: NCT04161066|
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : March 16, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder||Drug: Psilocybin with guided counseling||Phase 1|
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)).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open-label pilot study|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on Buprenorphine/Naloxone|
|Actual Study Start Date :||January 13, 2021|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Psilocybin with guided counseling: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.
Drug: Psilocybin with guided counseling
open-label pilot study
- Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [ Time Frame: approximately Week 1 ]In participants with OUD in early or sustained full recovery on buprenorphine/naloxone therapy, the safety of this intervention will be assessed by characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine/naloxone regimen.
- Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [ Time Frame: approximately Week 5 ]In participants with OUD in early or sustained full recovery on buprenorphine/naloxone therapy, the safety of this intervention will be assessed by characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine/naloxone regimen.
- Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument [ Time Frame: up to 5 weeks ]It is hypothesized that co-administration of oral psilocybin with buprenorphine/naloxone 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.
- Mean Change in Peripheral Capillary Oxygen [ Time Frame: up to 5 weeks ]It is hypothesized that co-administration of oral psilocybin with buprenorphine/naloxone will not cause opioid intoxication. Opioid intoxication will be determined by drops peripheral capillary oxygen saturation (SpO2) before and after dosing.
- Mean Change in ECG [ Time Frame: up to 5 weeks ]It is hypothesized that co-administration of oral psilocybin with buprenorphine/naloxone will not cause a clinically significant increase in the QTc interval. The QTc interval will be measured by electrocardiogram (ECG) before and after dosing. ECGs will be collected using the CardioCard PC computer-based system, once before the dose, and again at 1, 2, 3, 4, 6, and 8 hours after the dose. If a QTc(F), calculated by the CardioCard system exceeds 470msec, a study physician will be contacted immediately for further monitoring and treatment recommendations.
- Change in Opioid Craving Scale (OCS) from baseline through end of study [ Time Frame: Baseline, Week 1, Week 5, and Week 9 ]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 buprenorphine/naloxone 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.
- Mystical Effects Questionnaire (MEQ) after each dose [ Time Frame: approximately Week 1 and Week 5 ]To evaluate the effect of concurrent buprenorphine/naloxone use on the effects of psilocybin with guided counseling. The hypothesis is that co-administration of buprenorphine/naloxone with oral psilocybin will not be associated with a change in the effects of psilocybin, as measured by adverse events (Primary Outcome Measure), and the MEQ. The MEQ is a 30-item assessment used to characterize the consciousness-altering effects of psilocybin. Total possible range of scores is 0-150 where the higher the number the higher the consciousness-altering effects.
- Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB) [ Time Frame: up to 9 weeks ]It is hypothesized that co-administration of oral psilocybin with buprenorphine/naloxone 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161066
|Contact: Amy Baltes, MPHemail@example.com|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Contact: Amy Baltes, MPH 608-228-5325 firstname.lastname@example.org|
|Principal Investigator: Randall Brown, MD PhD|
|Principal Investigator:||Randall Brown, MD PhD||University of Wisconsin, Madison|