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NCT04161066 · ClinicalTrials.gov registry record · Phase 1
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
A Phase 1 study of Opioid Use Disorder, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04161066: Recruiting Phase 1 study of Opioid Use Disorder, sponsored by University of Wisconsin, Madison.
NCT04161066 is a Phase 1 study of Opioid Use Disorder that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 10 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04161066, a Phase 1 study of Opioid Use Disorder, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Psilocybin with facilitated counseling
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What NCT04161066 shows while recruiting
NCT04161066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin with facilitated counseling is the first listed.
NCT04161066 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04161066 about?
NCT04161066 is a clinical study titled "Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine". 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. Seco...
What is the current status of trial NCT04161066?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-01-13. Estimated completion is 2026-07.
What conditions does trial NCT04161066 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT04161066?
The interventions under investigation include: Psilocybin with facilitated counseling (DRUG).
Who is sponsoring clinical trial NCT04161066?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04161066 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04161066's enrollment target sits among peer trials
10 253rd of 257 higher than 1 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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