Psilocybin and Buprenorphine for Opioid Use Disorder
This study is looking at whether adding psilocybin (a psychedelic compound) to a standard treatment for opioid use disorder (OUD) called buprenorphine-naloxone is safe. Researchers want to see if psilocybin can be given safely to adults with OUD who are also taking buprenorphine-naloxone. They will also explore if psilocybin helps with the effectiveness of buprenorphine-naloxone and how buprenorphine-naloxone might affect psilocybin's effects. You might be able to join if you are 21-65 years old, have a moderate or severe OUD diagnosis, and are currently misusing opioids. The study plans to enroll 10 participants, but its current status is unclear.
- Study design
- This is an open-label pilot study, meaning both you and the researchers will know what treatment you are receiving. It is an interventional study, but the phase is not specified, and it plans to enroll 10 participants.
- What's involved
- You would take a daily dose of buprenorphine-naloxone, attend at least 6 hours of preparatory counseling, and receive two oral doses of psilocybin about 4 weeks apart. Each psilocybin dosing session involves 8 hours of observation, an overnight stay, and an integration session with a psychologist.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be measured 24 hours after each psilocybin dose (around Week 1 and Week 5). Opioid withdrawal symptoms will be tracked for up to 5 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Randall Brown, MD PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-doseapproximately Week 1
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.
- Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-doseapproximately Week 5
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.
- Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrumentup to 5 weeks
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.
- Mean Change in Peripheral Capillary Oxygenup to 5 weeks
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.
- Mean Change in ECGup to 5 weeks
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.