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Active, not recruitingN/A

Observational Pilot Study to Explore the Social and Health Impacts of a New Model of Care in Oregon: Psilocybin Services on Alcoholism

NCT07189988 · Healing Advocacy Fund

Closed to entry
Status
Not accepting participants
Not applicable
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose for this study is to observe the real world experience of participants who are receiving psilocybin in the context of (alcoholism) Alcohol Use Disorder without intervening in the model of care. The study team will engage directly with the participants to examine the outcomes in participants who have been deemed eligible and appropriate to receive psilocybin services at Oregon's Innertrek Patient Service Center (PSC) and who are willing to participate in the People Science pilot study to share their experience concurrently. Since the participant will be making the informed decision to voluntarily take part in this concurrent observational study, there will be no "doctor-patient" relationship between the participant and the People Science Study Investigator. Study participants will receive the standard of care and medical management from Oregon's Innertrek Patient Service Center facilitators as deemed appropriate per their existing guidelines and practices. People Science will solely be operating as an observer, using an agnostic research data capture system to collect outcomes and follow participant experiences throughout the course of their treatment journey. The study will incorporate participant-reported outcome measures, questionnaires and surveys. The primary endpoint in collecting study data will be to observe the impact of the Psilocybin-Assisted care model on the frequency of heavy drinking days through quantitative and qualitative data analysis for people who struggle with alcohol use. Non-quantitative narratives will also be captured. Throughout the People Science study observations, participants will be in the direct care of the Oregon Patient Service Center facilitators. Findings from this study will contribute knowledge toward the understanding of the use of psilocybin in individuals with self-described alcoholism (AUD).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Frequency of Heavy Drinking

    Measured over 12 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion 1. Over 21 years old and reside in Portland, Oregon (all genders) 2. Have a personal smartphone device, internet access, and willing to download Chloe 3. Have been deemed appropriate for care by Oregon's Innertrek Patient Service Center (PSC) and eligible for psilocybin services 4. Willingness to complete study activities and assessments for the duration of the study Exclusion Note that #1-3 below are mandatory exclusions for psilocybin-assisted care as directed by the Oregon Health Authority. Any potential participant who: 1. Have a personal history of psychosis per the Oregon Health Authority 2. Have active use of lithium per the Oregon Health Authority 3. Exhibit active thoughts of suicidality per the Oregon Health Authority 4. Are deemed ineligible for psilocybin services by Oregon's Innertrek Patient Service Center (PSC)

Where

1 study site

FacilityCityRegionCountry
Innertrek Patient Service CenterPortlandOregonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07189988 on ClinicalTrials.gov →

Last updated in the registry 2025-09-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in