Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04161066
Phase
PHASE1
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin with facilitated counseling — DRUG
    open-label pilot study

Study Details

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.

Key Dates

Start date
Jan 13, 2021
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Open-label
    Psilocybin with facilitated counseling: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.

Primary Outcome Measure

Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [ Time Frame: approximately Week 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Randall Brown, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Wisconsin· Madison, WI

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