Alcohol Use DisorderPhase 2NCT04410913
Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder
A Phase 2 study testing Psilocybin plus Visual Healing Set and Setting and Psilocybin plus Standard Set and Setting in people with Alcohol Use Disorder, run by Keith Heinzerling at 1 site in United States.
Trial summary
Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Psilocybin plus Visual Healing Set and Setting and Psilocybin plus Standard Set and Setting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to Feb 2023
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Able to read, speak, and understand English
- Alcohol use disorder, moderate-severe, according to DSM-5 criteria
- Interested in stopping or reducing alcohol use
- Able and willing to adhere to study requirements, including attending all study visits, preparatory, and follow-up sessions, and completing all study evaluations
- Able to swallow capsules
Show all 9Show fewer
- Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study
- Have an identified support person
- Agree to be driven home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
Who cannot join
- Alcohol withdrawal requiring medical intervention
- Women who are pregnant, or women who intend to become pregnant during the study or who are currently nursing
- Unwilling or unable to discontinue formal alcohol use disorder treatment
- Significant current or history of cardiovascular condition
- Have a history of stroke or Transient Ischemic Attack (TIA)
- Moderate to severe liver impairment
Show all 9Show fewer
- Epilepsy
- Insulin-dependent diabetes
- Diabetes and taking oral hypoglycemic agent with a history of hypoglycemia requiring serious medical intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Treatment & Research in Psychedelics
Santa Monica, California, 90404
About this study
Official title: Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder
Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The purpose of this study is to evaluate the feasibility, safety, and tolerability of adding Visual Healing, a nature-themed virtual immersive program, to psilocybin-assisted therapy among participants with alcohol use disorder.
Read the detailed description
The objective of the study is to test a strategy for optimizing Set and Setting for psilocybin-assisted therapy of alcohol use disorder. Psilocybin shows promise in early trials for alcohol use disorder, but initial results suggest that patients with alcohol use disorder may be less likely to achieve a mystical experience with standard doses of psilocybin. Optimizing Set and Setting for the psilocybin experience may improve outcomes without requiring higher drug doses. The current study will complete a pilot randomized clinical trial to assess the feasibility, safety, and tolerability of Visual Healing Set and Setting (N=10) versus standard Set and Setting procedures (N=10) in participants with alcohol use disorder undergoing open-label psilocybin 25 mg therapy. In the Visual Healing condition, participants will view nature-themed video programs during the Prep session and during the Ascent phase of the psilocybin experience. Anecdotal reports and reviews suggest that viewing Visual Healing creates a tranquil and calming environment that fosters a stronger connection between the viewer and nature. Psilocybin increases the users feeling of connection to nature and having an intention to connect with nature during the psychedelic session is associated with better outcomes of psychedelic-assisted therapy in initial studies. Reducing pre-dosing anxiety/apprehension and enhancing connections to nature with Visual Healing may improve outcomes of psychedelic-assisted therapy without the need for higher psilocybin doses.
- Conditions
- Alcohol Use Disorder
- Being tested
- Psilocybin plus Visual Healing Set and Setting, Psilocybin plus Standard Set and Setting
- Keywords
- Psilocybin, Psychedelics, Alcohol Use Disorder, Alcoholism, Psychedelic-assisted Therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin plus Visual Healing Set and SettingDrug
Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).
Psilocybin plus Standard Set and SettingDrug
Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).
| Study group | Role | What they receive |
|---|---|---|
| Visual Healing Set and Setting | Experimental | Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling. Receives: Drug: Psilocybin plus Visual Healing Set and Setting |
| Standard Set and Setting | Active comparator | Participants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling. Receives: Drug: Psilocybin plus Standard Set and Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Enroll at least 70% of target number of participants
Measured: Week 10
Feasibility: Retention Rate
Participants complete at least 70% of post-randomization visits
Measured: week 10
Tolerability: Number of Visual Healing segments viewed by participants
Average number of segments viewed
Measured: Week 7
Safety/Tolerability: number of Adverse Events
Average number of adverse events (side effects)
Measured: Week 14
Safety: Systolic Blood Pressure
Systolic blood pressure during dosing sessions
Measured: Week 14
Safety: Diastolic Blood Pressure
Diastolic blood pressure during dosing sessions
Measured: Week 14
Safety: Heart rate
Heart rate during dosing sessions
Measured: Week 14
Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score
Average change in anxiety scale score from prep session to dosing session
Measured: Week 14
Safety: Challenging Experience Questionnaire (CEQ)
Average score on challenging psychedelic experience scale
Measured: Week 14
Safety: Questionnaire for Psychotic Experiences
Average score on psychosis symptom scale
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start18 Feb 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keith Heinzerling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Keith Heinzerling, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410913
- Sponsor's protocol ID
- PTRIP002
- Status last verified
- Jan 2023
- First submitted
- 18 May 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13.
PubMed 25586396Bogenschutz MP, Podrebarac SK, Duane JH, Amegadzie SS, Malone TC, Owens LT, Ross S, Mennenga SE. Clinical Interpretations of Patient Experience in a Trial of Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder. Front Pharmacol. 2018 Feb 20;9:100. doi: 10.3389/fphar.2018.00100. eCollection 2018.
PubMed 29515439Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.
PubMed 28353056Carbonaro TM, Bradstreet MP, Barrett FS, MacLean KA, Jesse R, Johnson MW, Griffiths RR. Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. J Psychopharmacol. 2016 Dec;30(12):1268-1278. doi: 10.1177/0269881116662634. Epub 2016 Aug 30.
PubMed 27578767Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.
PubMed 29119217Dos Santos RG, Bouso JC, Alcazar-Corcoles MA, Hallak JEC. Efficacy, tolerability, and safety of serotonergic psychedelics for the management of mood, anxiety, and substance-use disorders: a systematic review of systematic reviews. Expert Rev Clin Pharmacol. 2018 Sep;11(9):889-902. doi: 10.1080/17512433.2018.1511424. Epub 2018 Aug 23.
PubMed 30102078Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
PubMed 27909165Hasler F, Bourquin D, Brenneisen R, Bar T, Vollenweider FX. Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharm Acta Helv. 1997 Jun;72(3):175-84. doi: 10.1016/s0031-6865(97)00014-9.
PubMed 9204776Johnson M, Richards W, Griffiths R. Human hallucinogen research: guidelines for safety. J Psychopharmacol. 2008 Aug;22(6):603-20. doi: 10.1177/0269881108093587. Epub 2008 Jul 1.
PubMed 18593734Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.
PubMed 28585222Johnson MW, Griffiths RR, Hendricks PS, Henningfield JE. The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act. Neuropharmacology. 2018 Nov;142:143-166. doi: 10.1016/j.neuropharm.2018.05.012. Epub 2018 Jun 5.
PubMed 29753748Rich R, Laird K, Siddarth P, Youssef B, Schwartz GM, Ramos A, Sergi K, Linton M, Schwartzberg L, Kelly DF, Heinzerling KG. A Nature-Themed Video Intervention Increases Nature Relatedness in Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder. Psychedelic Med (New Rochelle). 2025 Dec 26;4(3):199-208. doi: 10.1177/28314425251387655. eCollection 2026 Sep.
PubMed 42539824
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04410913
- Acronym / sponsor ID
- PTRIP002
- Conditions
- Alcohol Use Disorder
- Keywords
- Psilocybin, Psychedelics, Alcohol Use Disorder, Alcoholism, Psychedelic-assisted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Keith HeinzerlingUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 1 Jun 2020 (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.
Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10) versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The purpose of this study is to evaluate the feasibility, safety, and tolerability of adding Visual Healing, a nature-themed virtual immersive program, to psilocybin-assisted therapy among participants with alcohol use disorder.
Detailed description
The objective of the study is to test a strategy for optimizing Set and Setting for psilocybin-assisted therapy of alcohol use disorder. Psilocybin shows promise in early trials for alcohol use disorder, but initial results suggest that patients with alcohol use disorder may be less likely to achieve a mystical experience with standard doses of psilocybin. Optimizing Set and Setting for the psilocybin experience may improve outcomes without requiring higher drug doses. The current study will complete a pilot randomized clinical trial to assess the feasibility, safety, and tolerability of Visual Healing Set and Setting (N=10) versus standard Set and Setting procedures (N=10) in participants with alcohol use disorder undergoing open-label psilocybin 25 mg therapy. In the Visual Healing condition, participants will view nature-themed video programs during the Prep session and during the Ascent phase of the psilocybin experience. Anecdotal reports and reviews suggest that viewing Visual Healing creates a tranquil and calming environment that fosters a stronger connection between the viewer and nature. Psilocybin increases the users feeling of connection to nature and having an intention to connect with nature during the psychedelic session is associated with better outcomes of psychedelic-assisted therapy in initial studies. Reducing pre-dosing anxiety/apprehension and enhancing connections to nature with Visual Healing may improve outcomes of psychedelic-assisted therapy without the need for higher psilocybin doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Visual Healing Set and Setting | Experimental | Drug: Psilocybin plus Visual Healing Set and SettingParticipants in this group will receive a single 25 mg dose of open-label psilocybin along with the Visual Healing Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling. |
| Standard Set and Setting | Active comparator | Drug: Psilocybin plus Standard Set and SettingParticipants in this group will receive a single 25 mg dose of open-label psilocybin along with the Standard Set and Setting protocol. Psilocybin is administered orally as a capsule and taken with water. Four weeks later all participants will undergo a second open-label psilocybin 25 mg session where participants will choose to receive Visual Healing or standard Set and Setting procedures. All participants will receive Prep and Integration counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Able to read, speak, and understand English
- Alcohol use disorder, moderate-severe, according to DSM-5 criteria
- Interested in stopping or reducing alcohol use
- Able and willing to adhere to study requirements, including attending all study visits, preparatory, and follow-up sessions, and completing all study evaluations
Key exclusion criteria (9 listed)
- Alcohol withdrawal requiring medical intervention
- Women who are pregnant, or women who intend to become pregnant during the study or who are currently nursing
- Unwilling or unable to discontinue formal alcohol use disorder treatment
- Significant current or history of cardiovascular condition
- Have a history of stroke or Transient Ischemic Attack (TIA)
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 |
|---|---|---|
| Psilocybin plus Visual Healing Set and SettingPsychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice). | Drug | Visual Healing Set and Setting |
| Psilocybin plus Standard Set and SettingPsychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice). | Drug | Standard Set and Setting |
Primary outcome
Feasibility: Recruitment Rate
Time frame: Week 10
Enroll at least 70% of target number of participants
Feasibility: Retention Rate
Time frame: week 10
Participants complete at least 70% of post-randomization visits
Tolerability: Number of Visual Healing segments viewed by participants
Time frame: Week 7
Average number of segments viewed
Safety/Tolerability: number of Adverse Events
Time frame: Week 14
Average number of adverse events (side effects)
Safety: Systolic Blood Pressure
Time frame: Week 14
Systolic blood pressure during dosing sessions
Safety: Diastolic Blood Pressure
Time frame: Week 14
Diastolic blood pressure during dosing sessions
Safety: Heart rate
Time frame: Week 14
Heart rate during dosing sessions
Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score
Time frame: Week 14
Average change in anxiety scale score from prep session to dosing session
Safety: Challenging Experience Questionnaire (CEQ)
Time frame: Week 14
Average score on challenging psychedelic experience scale
Safety: Questionnaire for Psychotic Experiences
Time frame: Week 14
Average score on psychosis symptom scale
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 17 Jan 2023.
- Background: PubMed 25586396Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13.
- Background: PubMed 29515439Bogenschutz MP, Podrebarac SK, Duane JH, Amegadzie SS, Malone TC, Owens LT, Ross S, Mennenga SE. Clinical Interpretations of Patient Experience in a Trial of Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder. Front Pharmacol. 2018 Feb 20;9:100. doi: 10.3389/fphar.2018.00100. eCollection 2018.
- Background: PubMed 28353056Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.
- Background: PubMed 27578767Carbonaro TM, Bradstreet MP, Barrett FS, MacLean KA, Jesse R, Johnson MW, Griffiths RR. Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. J Psychopharmacol. 2016 Dec;30(12):1268-1278. doi: 10.1177/0269881116662634. Epub 2016 Aug 30.
- Background: PubMed 29119217Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8.
- Background: PubMed 30102078Dos Santos RG, Bouso JC, Alcazar-Corcoles MA, Hallak JEC. Efficacy, tolerability, and safety of serotonergic psychedelics for the management of mood, anxiety, and substance-use disorders: a systematic review of systematic reviews. Expert Rev Clin Pharmacol. 2018 Sep;11(9):889-902. doi: 10.1080/17512433.2018.1511424. Epub 2018 Aug 23.
- Background: PubMed 27909165Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
- Background: PubMed 9204776Hasler F, Bourquin D, Brenneisen R, Bar T, Vollenweider FX. Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharm Acta Helv. 1997 Jun;72(3):175-84. doi: 10.1016/s0031-6865(97)00014-9.
- Background: PubMed 18593734Johnson M, Richards W, Griffiths R. Human hallucinogen research: guidelines for safety. J Psychopharmacol. 2008 Aug;22(6):603-20. doi: 10.1177/0269881108093587. Epub 2008 Jul 1.
- Background: PubMed 28585222Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.
- Background: PubMed 29753748Johnson MW, Griffiths RR, Hendricks PS, Henningfield JE. The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act. Neuropharmacology. 2018 Nov;142:143-166. doi: 10.1016/j.neuropharm.2018.05.012. Epub 2018 Jun 5.
- Derived from this study: PubMed 42539824Rich R, Laird K, Siddarth P, Youssef B, Schwartz GM, Ramos A, Sergi K, Linton M, Schwartzberg L, Kelly DF, Heinzerling KG. A Nature-Themed Video Intervention Increases Nature Relatedness in Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder. Psychedelic Med (New Rochelle). 2025 Dec 26;4(3):199-208. doi: 10.1177/28314425251387655. eCollection 2026 Sep.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin plus Visual Healing Set and Setting and Psilocybin plus Standard Set and Setting in people with Alcohol Use Disorder, run by Keith Heinzerling 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 9 inclusion and 9 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 17 Jan 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility: Recruitment Rate (time frame: Week 10). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410913, which also lists 12 linked publications.
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 17 Jan 2023.