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Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine

NCT04161066 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Psilocybin with facilitated counseling

open-label pilot study

Sponsors & Collaborators

  • Heffter Research Institute

    collaborator OTHER

  • Etheridge Foundation

    collaborator UNKNOWN

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Randall Brown, MD PhD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161066 on ClinicalTrials.gov