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

NCT07189988 | Active Not Recruiting

• 1 other identifier: PS13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alcohol Use Disorder

Keywords

alcoholism; alcohol use disorder

Outcome Measures

Primary Outcomes (1)

• Frequency of Heavy Drinking

  The primary objective is to study the effects of Oregon Health Authority's (OHA's) psilocybin service program on frequency of heavy drinking among people with alcohol use disorder. This will measured by Percentage of number of heavy drinking days at baseline versus in 30 day increments after completing psilocybin services.

  12 months

Secondary Outcomes (7)

• Number of Drinking Days

  12 months

• Days of Complete Abstinence

  12 months

• Diagnostic and Statistical Manual of Mental Disorder (DSM) early remission

  12 months

• Alcohol Craving

  12 months

• Spiritual Significance

  12 months

Other Outcomes (4)

• Alcohol Abstinence Self-Efficacy

  12 months

• Life Quality

  12 months

• Individual Experiences

  12 months

Study Arms (3)

Cohort 1

All study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey.

Other: psilocybin

Cohort 2

All study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey.

Other: psilocybin

Cohort 3

All study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey.

Other: psilocybin

Interventions

psilocybin OTHER

All study participants were provided low dose psilocybin.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be recruited through Oregon's Innertrek Patient Service Center (PSC). They will exhibit struggles with alcoholism or alcohol use disorder, deemed appropriate for care by Oregon's Innertrek Patient Service Center, and eligible for psilocybin services. Once eligibility at the PSC has been determined, eligible participants will be invited to voluntarily participate in the People Science pilot observational research study.

You may qualify if:

• Over 21 years old and reside in Portland, Oregon (all genders)
• Have a personal smartphone device, internet access, and willing to download Chloe
• Have been deemed appropriate for care by Oregon's Innertrek Patient Service Center (PSC) and eligible for psilocybin services
• Willingness to complete study activities and assessments for the duration of the study

You may not qualify if:

• Have a personal history of psychosis per the Oregon Health Authority
• Have active use of lithium per the Oregon Health Authority
• Exhibit active thoughts of suicidality per the Oregon Health Authority
• Are deemed ineligible for psilocybin services by Oregon's Innertrek Patient Service Center (PSC)

Sponsors & Collaborators

• Healing Advocacy Fund: lead
• People Science, Inc.: collaborator

Study Sites (1)

Innertrek Patient Service Center

Portland, Oregon, 97232, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Noah Craft, MD

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)