Alcohol Use DisorderNCT07189988
Observational Pilot Study to Explore the Social and Health Impacts of a New Model of Care in Oregon: Psilocybin Services on Alcoholism
An observational study of Alcohol Use Disorder, run by Healing Advocacy Fund at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- psilocybin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 5 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Note that #1-3 below are mandatory exclusions for psilocybin-assisted care as directed by the Oregon Health Authority. Any potential participant who:
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Innertrek Patient Service Center
Portland, Oregon, 97232
About this study
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).
Read the detailed description
Alcoholism or Alcohol Use Disorder (AUD) is a chronic and relapsing condition characterized by an inability to control alcohol consumption, leading to significant health, social, and economic consequences. Despite the availability of various treatment modalities, including pharmacotherapies and behavioral interventions, relapse rates remain high, with many individuals failing to achieve long-term abstinence or control. This has spurred interest in exploring novel therapeutic approaches and care models, including the potential use of psychedelic compounds such as psilocybin used in a supportive care environment.
Psilocybin, a naturally occurring psychoactive substance found in certain species of mushrooms, has garnered attention for its potential therapeutic effects in treating mental health disorders such as depression, anxiety, and post-traumatic stress disorder. More recently, research has suggested that psilocybin may be beneficial in addressing substance use disorders, including Alcohol Use Disorder. The mechanism by which psilocybin exerts its effects appears to involve the modulation of neural circuits related to mood regulation, behavior, and self-reflection, which can facilitate profound psychological experiences that may promote lasting changes in behavior and cognition.
Early clinical trials have shown promising results, indicating that psilocybin, when administered in a therapeutic setting, can reduce alcohol consumption and cravings in individuals with Alcohol Use Disorder. In a study published in Journal of American Medical Association of Psychiatry, researchers from New York University Grossman School of Medicine found that heavy alcohol consumption among people with alcohol use disorders was 83 percent lower among participants who had received psilocybin over an 8-month period following the psilocybin administration and almost half of participants who received psilocybin stopped drinking alcohol altogether. These studies highlight the potential for psilocybin to act as a catalyst for psychological insights and behavioral change when combined with psychotherapy or a calming and supportive environment, offering a new avenue for treatment-resistant cases of Alcohol Use Disorder.
In Oregon, excessive alcohol consumption causes 2,000 deaths each year, making it the third leading cause of preventable death in the state. There is a glaring need for support for Oregonians facing alcohol and substance use disorders. Alongside more traditional treatment and harm reduction models, Psilocybin shows promise for treating alcohol and substance disorders. Oregon's state-regulated psilocybin program offers an opportunity to advance real world research on Psilocybin for treating alcohol and substance use disorders.
In 2020, Oregon voters approved a ballot measure (Measure 109) to create the world's first state-regulated psilocybin program to improve the physical, mental, and social well-being of all people. The measure required that the Oregon Health Authority (OHA) create a licensing and regulatory framework for a safe, accessible and equitable program. After a two-year rule making period, licensed service centers are now open and providing psilocybin services to clients in Oregon. Psilocybin services are only delivered in licensed service centers, under the supervision of a trained facilitator, and psilocybin can only be consumed in the service center during that supervised session. There are no retail sales, no off-site consumption, possession, or production of psilocybin (outside of licensed manufacturers).
The sponsor of this pilot research project is the Healing Advocacy Fund (HAF). HAF is a 501c3 non-profit organization that advocates for safe, affordable state-regulated access to psychedelic services. The Healing Advocacy Fund promotes regulations that create a state psilocybin program that is of high quality, accessible, and maximizes safety; educates stakeholders, policymakers, regulators, and the general public on the Oregon psilocybin program; and serves as a convener for the Oregon psilocybin ecosystem to collaboratively address goals and challenges, organize around shared needs, and deliver services to high standards and best practices.
InnerTrek will provide the psilocybin services to individuals who struggle with alcohol use for the pilot. InnerTrek is a psilocybin patient service center located in Portland, Oregon and licensed by the Oregon Health Authority to offer both individual and group psilocybin services, including preparation, administration, and integration sessions.
The position of the People Science research team in this setting is to observe the practices and experiences already occurring in the context of the State of Oregon's Psilocybin Services program at the InnerTrek Patient Service Center. People Science will create the questionnaires to be offered to the participants, as well as analyze data on the observation of participants' perspectives.
- Conditions
- Alcohol Use Disorder
- Being tested
- psilocybin
- Keywords
- alcoholism, alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psilocybinOther
All study participants were provided low dose psilocybin.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | All study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey. Receives: 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. Receives: 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. Receives: Other: psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Number of Drinking Days
A secondary objective of this study is to observe the impact of the Oregon Health Authority's Psilocybin program in the context of Alcohol Use Disorder on drinking days. This will be measured by the number of drinking days per month (including heavy and non-heavy drinking).
Measured: 12 months
Days of Complete Abstinence
A secondary objective of this study is to observe the impact of Oregon Health Authority's Psilocybin program in the context of Alcohol Use Disorder on percentage of days of complete abstinence at regular intervals after treatment. This will be measured by the number of days abstinent from alcohol per month.
Measured: 12 months
Diagnostic and Statistical Manual of Mental Disorder (DSM) early remission
A secondary objective of this study is to observe the impact of Oregon Health Authority's Psilocybin program in the context of Alcohol Use Disorder on prevalence of Diagnostic and Statistical Manual of Mental Disorder early remission criteria at regular intervals after treatment. This will be measured by the percentage of participants who meet Diagnostic and Statistical Manual of Mental Disorder early remission criteria at 3 months, and percentage who achieved abstinence at monthly intervals after psilocybin services.
Measured: 12 months
Alcohol Craving
A secondary objective is to observe the impact of Oregon Health Authority's (OHA's) Psilocybin program in the context of Alcohol Use Disorder on subjective alcohol craving. This will be measured by alcohol cravings at the end of each month as measured by the Brief Substance Craving Scale (8-Item).
Measured: 12 months
Spiritual Significance
A secondary objective is to observe the spiritual significance, if any, of participants using Oregon Health Authority's Psilocybin program in the context of Alcohol Use Disorder. This will be measured by the spiritual significance of the program as assessed by the Rating of Spiritual Meaning (FACIT-Sp) questionnaire on a monthly basis.
Measured: 12 months
Treatment Completion Rate
A secondary objective is to evaluate the completion rate of the treatment protocol and any reasons for discontinuation among participants. This will be measured by the percentage of participants who complete the program and reasons for discontinuation on an ongoing basis throughout the course of the 12 month study.
Measured: 12 months
Adverse Events
A secondary objective of the study is to observe the rate of adverse events in Oregon Health Authority's Psilocybin program in the context of Alcohol Use Disorder. This will be measured by the severity and frequency of adverse events assessed weekly during treatment and monthly following treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start5 Mar 2025
- Primary completion10 Jun 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healing Advocacy Fund
- Sponsor type
- University, hospital or other
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189988
- Sponsor's protocol ID
- PS13
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will require further internal discussion.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Pilot Study to Explore the Social and Health Impacts of a New Model of Care in Oregon: Psilocybin Services on Alcoholism
- ClinicalTrials.gov ID
- NCT07189988
- Acronym / sponsor ID
- PS13
- Conditions
- Alcohol Use Disorder
- Keywords
- alcoholism, alcohol use disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Healing Advocacy FundUniversity, hospital or other
- Collaborators
- People Science, Inc.
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Alcoholism or Alcohol Use Disorder (AUD) is a chronic and relapsing condition characterized by an inability to control alcohol consumption, leading to significant health, social, and economic consequences. Despite the availability of various treatment modalities, including pharmacotherapies and behavioral interventions, relapse rates remain high, with many individuals failing to achieve long-term abstinence or control. This has spurred interest in exploring novel therapeutic approaches and care models, including the potential use of psychedelic compounds such as psilocybin used in a supportive care environment.
Psilocybin, a naturally occurring psychoactive substance found in certain species of mushrooms, has garnered attention for its potential therapeutic effects in treating mental health disorders such as depression, anxiety, and post-traumatic stress disorder. More recently, research has suggested that psilocybin may be beneficial in addressing substance use disorders, including Alcohol Use Disorder. The mechanism by which psilocybin exerts its effects appears to involve the modulation of neural circuits related to mood regulation, behavior, and self-reflection, which can facilitate profound psychological experiences that may promote lasting changes in behavior and cognition.
Early clinical trials have shown promising results, indicating that psilocybin, when administered in a therapeutic setting, can reduce alcohol consumption and cravings in individuals with Alcohol Use Disorder. In a study published in Journal of American Medical Association of Psychiatry, researchers from New York University Grossman School of Medicine found that heavy alcohol consumption among people with alcohol use disorders was 83 percent lower among participants who had received psilocybin over an 8-month period following the psilocybin administration and almost half of participants who received psilocybin stopped drinking alcohol altogether. These studies highlight the potential for psilocybin to act as a catalyst for psychological insights and behavioral change when combined with psychotherapy or a calming and supportive environment, offering a new avenue for treatment-resistant cases of Alcohol Use Disorder.
In Oregon, excessive alcohol consumption causes 2,000 deaths each year, making it the third leading cause of preventable death in the state. There is a glaring need for support for Oregonians facing alcohol and substance use disorders. Alongside more traditional treatment and harm reduction models, Psilocybin shows promise for treating alcohol and substance disorders. Oregon's state-regulated psilocybin program offers an opportunity to advance real world research on Psilocybin for treating alcohol and substance use disorders.
In 2020, Oregon voters approved a ballot measure (Measure 109) to create the world's first state-regulated psilocybin program to improve the physical, mental, and social well-being of all people. The measure required that the Oregon Health Authority (OHA) create a licensing and regulatory framework for a safe, accessible and equitable program. After a two-year rule making period, licensed service centers are now open and providing psilocybin services to clients in Oregon. Psilocybin services are only delivered in licensed service centers, under the supervision of a trained facilitator, and psilocybin can only be consumed in the service center during that supervised session. There are no retail sales, no off-site consumption, possession, or production of psilocybin (outside of licensed manufacturers).
The sponsor of this pilot research project is the Healing Advocacy Fund (HAF). HAF is a 501c3 non-profit organization that advocates for safe, affordable state-regulated access to psychedelic services. The Healing Advocacy Fund promotes regulations that create a state psilocybin program that is of high quality, accessible, and maximizes safety; educates stakeholders, policymakers, regulators, and the general public on the Oregon psilocybin program; and serves as a convener for the Oregon psilocybin ecosystem to collaboratively address goals and challenges, organize around shared needs, and deliver services to high standards and best practices.
InnerTrek will provide the psilocybin services to individuals who struggle with alcohol use for the pilot. InnerTrek is a psilocybin patient service center located in Portland, Oregon and licensed by the Oregon Health Authority to offer both individual and group psilocybin services, including preparation, administration, and integration sessions.
The position of the People Science research team in this setting is to observe the practices and experiences already occurring in the context of the State of Oregon's Psilocybin Services program at the InnerTrek Patient Service Center. People Science will create the questionnaires to be offered to the participants, as well as analyze data on the observation of participants' perspectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: psilocybinAll study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey. |
| Cohort 2 | – | Other: psilocybinAll study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey. |
| Cohort 3 | – | Other: psilocybinAll study participants were divided into three cohorts to provide ample time between the participants and facilitators during the psilocybin journey. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Note that #1-3 below are mandatory exclusions for psilocybin-assisted care as directed by the Oregon Health Authority. Any potential participant who:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psilocybinAll study participants were provided low dose psilocybin. | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Frequency of Heavy Drinking
Time frame: 12 months
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.
7 secondary outcomes
Number of Drinking Days
Time frame: 12 months
Days of Complete Abstinence
Time frame: 12 months
Diagnostic and Statistical Manual of Mental Disorder (DSM) early remission
Time frame: 12 months
Alcohol Craving
Time frame: 12 months
Spiritual Significance
Time frame: 12 months
Treatment Completion Rate
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Undecided. Will require further internal discussion.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by Healing Advocacy Fund at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Heavy Drinking (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.