Clinical TrialOpioid Use Disorder (OUD)PsilocybinRecruiting

Adjunctive Effects of Psilocybin and Buprenorphine

Open-label single-group Phase I study (n=10) assessing safety of two oral psilocybin doses added to a stable buprenorphine-naloxone regimen in adults with opioid use disorder.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label single-group pilot testing two oral psilocybin doses administered ~4 weeks apart to participants with OUD maintained on buprenorphine-naloxone; dosing occurs in capsules with two trained facilitators present.

Each dosing day includes at least 6 hours of preparatory counselling, approximately 8 hours of acute observation in the dosing room followed by overnight hospital observation, and an integration session with a psychologist prior to discharge.

Primary outcome is safety of concurrent psilocybin and buprenorphine-naloxone assessed by physiological measures (ECG, respiratory rate, BP, temperature, SpO2) and clinical/self-report instruments including COWS and opioid craving measures; secondary aims examine effects on buprenorphine effectiveness and self-efficacy/quality of life.

Study Protocol

Preparation

1 sessions
360 min each

Dosing

2 sessions
480 min each

Integration

1 sessions

Study Arms & Interventions

Psilocybin + buprenorphine

experimental

Open-label single-group: two oral psilocybin doses (~4 weeks apart) with facilitated counselling and overnight observation.

Interventions

  • Psilocybin
    via Oral• two sessions• 2 doses total

    Oral capsules; dosing attended by two trained facilitators; open-label

Participants

Ages
21 – 65
Sexes
Male & Female

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/naloxone; see exclusion #1). Misuse defined as either:
  • 1. Use of illicit opioids (e.g., heroin, street fentanyl), or non-approved route use of prescription opioids (e.g., nasal, injected), and/or
  • 2. Use of a prescription opioid for a purpose other than prescribed (e.g., intoxication)
  • Able to achieve stable daily dose of a buprenorphine-naloxone formulation that controls opioid withdrawal symptoms
  • Persons of childbearing potential must agree to effective contraception throughout participation
  • Ability and willingness to adhere to study requirements, including attending study visits, preparatory and follow-up sessions
  • Healthy kidney function
  • Able to provide contact information for a local support person available during 24-hour treatment/observation periods

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 (participation may violate terms of supervision)
  • 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 (Type I or II diabetes)
  • Urine drug test positive for non-prescribed drugs of abuse
  • Any finding(s) based on screening that the PI deems makes the study unsuitable for the participant

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2021-01-13
    End: 2022-08-01
  • Compound
    Psilocybin
  • Topic
    Opioid Use Disorder (OUD)

Locations

University of Wisconsin — Madison, Wisconsin, United States

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