<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04410913</url>
  </required_header>
  <id_info>
    <org_study_id>PTRIP002</org_study_id>
    <nct_id>NCT04410913</nct_id>
  </id_info>
  <brief_title>Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keith Heinzerling</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint John's Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental&#xD;
      Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to&#xD;
      open-label psilocybin (25 mg) therapy with the Visual Healing Set and Setting platform (N=10)&#xD;
      versus psilocybin (25 mg) with a standard Set and Setting platform (N=10). The purpose of&#xD;
      this study is to evaluate the feasibility, safety, and tolerability of adding Visual Healing,&#xD;
      a nature-themed virtual immersive program, to psilocybin-assisted therapy among participants&#xD;
      with alcohol use disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study is to test a strategy for optimizing Set and Setting for&#xD;
      psilocybin-assisted therapy of alcohol use disorder. Psilocybin shows promise in early trials&#xD;
      for alcohol use disorder, but initial results suggest that patients with alcohol use disorder&#xD;
      may be less likely to achieve a mystical experience with standard doses of psilocybin.&#xD;
      Optimizing Set and Setting for the psilocybin experience may improve outcomes without&#xD;
      requiring higher drug doses. The current study will complete a pilot randomized clinical&#xD;
      trial to assess the feasibility, safety, and tolerability of Visual Healing Set and Setting&#xD;
      (N=10) versus standard Set and Setting procedures (N=10) in participants with alcohol use&#xD;
      disorder undergoing open-label psilocybin 25 mg therapy. In the Visual Healing condition,&#xD;
      participants will view nature-themed video programs during the Prep session and during the&#xD;
      Ascent phase of the psilocybin experience. Anecdotal reports and reviews suggest that viewing&#xD;
      Visual Healing creates a tranquil and calming environment that fosters a stronger connection&#xD;
      between the viewer and nature. Psilocybin increases the users feeling of connection to nature&#xD;
      and having an intention to connect with nature during the psychedelic session is associated&#xD;
      with better outcomes of psychedelic-assisted therapy in initial studies. Reducing pre-dosing&#xD;
      anxiety/apprehension and enhancing connections to nature with Visual Healing may improve&#xD;
      outcomes of psychedelic-assisted therapy without the need for higher psilocybin doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 18, 2021</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Recruitment Rate</measure>
    <time_frame>Week 10</time_frame>
    <description>Enroll at least 70% of target number of participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Retention Rate</measure>
    <time_frame>week 10</time_frame>
    <description>Participants complete at least 70% of post-randomization visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability: Number of Visual Healing segments viewed by participants</measure>
    <time_frame>Week 7</time_frame>
    <description>Average number of segments viewed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety/Tolerability: number of Adverse Events</measure>
    <time_frame>Week 14</time_frame>
    <description>Average number of adverse events (side effects)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Systolic Blood Pressure</measure>
    <time_frame>Week 14</time_frame>
    <description>Systolic blood pressure during dosing sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Diastolic Blood Pressure</measure>
    <time_frame>Week 14</time_frame>
    <description>Diastolic blood pressure during dosing sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Heart rate</measure>
    <time_frame>Week 14</time_frame>
    <description>Heart rate during dosing sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score</measure>
    <time_frame>Week 14</time_frame>
    <description>Average change in anxiety scale score from prep session to dosing session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Challenging Experience Questionnaire (CEQ)</measure>
    <time_frame>Week 14</time_frame>
    <description>Average score on challenging psychedelic experience scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Questionnaire for Psychotic Experiences</measure>
    <time_frame>Week 14</time_frame>
    <description>Average score on psychosis symptom scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Visual Healing Set and Setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Set and Setting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin plus Visual Healing Set and Setting</intervention_name>
    <description>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).</description>
    <arm_group_label>Visual Healing Set and Setting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psilocybin plus Standard Set and Setting</intervention_name>
    <description>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).</description>
    <arm_group_label>Standard Set and Setting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Able to read, speak, and understand English&#xD;
&#xD;
          -  Alcohol use disorder, moderate-severe, according to DSM-5 criteria&#xD;
&#xD;
          -  Interested in stopping or reducing alcohol use&#xD;
&#xD;
          -  Able and willing to adhere to study requirements, including attending all study&#xD;
             visits, preparatory, and follow-up sessions, and completing all study evaluations&#xD;
&#xD;
          -  Able to swallow capsules&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must agree to practice an effective means of&#xD;
             birth control throughout the duration of the study&#xD;
&#xD;
          -  Have an identified support person&#xD;
&#xD;
          -  Agree to be driven home (or to an otherwise safe destination) by the support person,&#xD;
             or another responsible party, following dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol withdrawal requiring medical intervention&#xD;
&#xD;
          -  Women who are pregnant, or women who intend to become pregnant during the study or who&#xD;
             are currently nursing&#xD;
&#xD;
          -  Unwilling or unable to discontinue formal alcohol use disorder treatment&#xD;
&#xD;
          -  Significant current or history of cardiovascular condition&#xD;
&#xD;
          -  Have a history of stroke or Transient Ischemic Attack (TIA)&#xD;
&#xD;
          -  Moderate to severe liver impairment&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Insulin-dependent diabetes&#xD;
&#xD;
          -  Diabetes and taking oral hypoglycemic agent with a history of hypoglycemia requiring&#xD;
             serious medical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pacific Treatment &amp; Research in Psychedelics</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25586396</PMID>
  </reference>
  <reference>
    <citation>Bogenschutz 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.</citation>
    <PMID>29515439</PMID>
  </reference>
  <reference>
    <citation>Brown 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.</citation>
    <PMID>28353056</PMID>
  </reference>
  <reference>
    <citation>Carbonaro 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.</citation>
    <PMID>27578767</PMID>
  </reference>
  <reference>
    <citation>Carhart-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.</citation>
    <PMID>29119217</PMID>
  </reference>
  <reference>
    <citation>Dos 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.</citation>
    <PMID>30102078</PMID>
  </reference>
  <reference>
    <citation>Griffiths 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.</citation>
    <PMID>27909165</PMID>
  </reference>
  <reference>
    <citation>Hasler 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.</citation>
    <PMID>9204776</PMID>
  </reference>
  <reference>
    <citation>Johnson 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.</citation>
    <PMID>18593734</PMID>
  </reference>
  <reference>
    <citation>Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.</citation>
    <PMID>28585222</PMID>
  </reference>
  <reference>
    <citation>Johnson 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.</citation>
    <PMID>29753748</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Saint John's Cancer Institute</investigator_affiliation>
    <investigator_full_name>Keith Heinzerling</investigator_full_name>
    <investigator_title>Director, Pacific Treatment &amp; Research In Psychedelics Program</investigator_title>
  </responsible_party>
  <keyword>Psilocybin</keyword>
  <keyword>Psychedelics</keyword>
  <keyword>Alcohol Use Disorder</keyword>
  <keyword>Alcoholism</keyword>
  <keyword>Psychedelic-assisted Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psilocybin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410913
org study id: PTRIP002
nct id: NCT04410913
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Feasibility: Recruitment Rate
time frame: Week 10
description: Enroll at least 70% of target number of participants
measure: Feasibility: Retention Rate
time frame: week 10
description: Participants complete at least 70% of post-randomization visits
measure: Tolerability: Number of Visual Healing segments viewed by participants
time frame: Week 7
description: Average number of segments viewed
measure: Safety/Tolerability: number of Adverse Events
time frame: Week 14
description: Average number of adverse events (side effects)
measure: Safety: Systolic Blood Pressure
time frame: Week 14
description: Systolic blood pressure during dosing sessions
measure: Safety: Diastolic Blood Pressure
time frame: Week 14
description: Diastolic blood pressure during dosing sessions
measure: Safety: Heart rate
time frame: Week 14
description: Heart rate during dosing sessions
measure: Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score
time frame: Week 14
description: Average change in anxiety scale score from prep session to dosing session
measure: Safety: Challenging Experience Questionnaire (CEQ)
time frame: Week 14
description: Average score on challenging psychedelic experience scale
measure: Safety: Questionnaire for Psychotic Experiences
time frame: Week 14
description: Average score on psychosis symptom scale
arm group label: Visual Healing Set and Setting
arm group type: Experimental
description: 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.
arm group label: Standard Set and Setting
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: Psilocybin plus Visual Healing Set and Setting
description: 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).
arm group label: Visual Healing Set and Setting
intervention type: Drug
intervention name: Psilocybin plus Standard Set and Setting
description: 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).
arm group label: Standard Set and Setting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: 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.
PMID: 25586396
citation: Bogenschutz 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.
PMID: 29515439
citation: Brown 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.
PMID: 28353056
citation: Carbonaro 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.
PMID: 27578767
citation: Carhart-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.
PMID: 29119217
citation: Dos 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.
PMID: 30102078
citation: Griffiths 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.
PMID: 27909165
citation: Hasler 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.
PMID: 9204776
citation: Johnson 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.
PMID: 18593734
citation: Johnson MW, Griffiths RR. Potential Therapeutic Effects of Psilocybin. Neurotherapeutics. 2017 Jul;14(3):734-740. doi: 10.1007/s13311-017-0542-y.
PMID: 28585222
citation: Johnson 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.
PMID: 29753748
responsible party type: Sponsor-Investigator
investigator affiliation: Saint John's Cancer Institute
investigator full name: Keith Heinzerling
investigator title: Director, Pacific Treatment & Research In Psychedelics Program
mesh term: Alcoholism
mesh term: Alcohol Drinking
mesh term: Psilocybin