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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04161066
The ClinicalTrials.gov registry entry for NCT04161066 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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