Warrior CARE: Cannabis Behavioral Health

NCT06381180 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Warrior CARE: CBH
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

Conditions

Post Traumatic Stress Disorder; Cannabis Use; Suicide; Veterans; Marijuana

Outcome Measures

Primary Outcomes (5)

• Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.

  PTSD diagnosis will be assessed using the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5 Total Severity Score, a well-validated, semi-structured clinician interview that determines the presence and severity of PTSD symptoms and diagnosis consistent with the DSM-5 and allows for assessing changes in symptom severity over time.

  Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

• Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment

  The PCL-5 is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD. The PCL-5 is used to monitor symptom change during and after treatment, screen individuals for PTSD, and make a provisional PTSD diagnosis. This assessment will also be used as a safety measure at all visits by assessing PTSD symptom severity.

  Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

• Assessing Suicidality over time using the C-SSRS assessment.

  The Columbia Suicide Severity Rating Scale (C-SSRS) is a clinician-administered interview assessing suicidal thoughts and behaviors over time. A baseline form is used to assess lifetime suicidal ideation, intensity, and behavior, and can be compared to current suicidal ideation and intensity assessed over the clinical trial.

  Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

• Assessing Suicidality throughout the study using the SBQ-R assessment.

  The Suicide Behavior Questionnaire-Revised (SBQ-R) is a brief (4-item), self-administered questionnaire that taps into four dimensions of suicidality (lifetime ideation/attempt, frequency of recent ideation, risk of suicide attempt and self-reported likelihood of future suicidal behavior). This assessment will also be used as a safety measure at all visits by assessing suicidality.

  Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

• Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires.

  The Beck Depression Inventory-II (BDI-II) is a self-report depression checklist which assesses neurovegetative depressive symptoms. One item asks specifically about suicidal thoughts and will also be checked at every study visit as a safety measure. The State Trait Anxiety Inventory-Form Y (STAI-Y) is a 40-item questionnaire with two scales assessing state and trait anxiety (somatic and cognitive symptoms).

  Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

Secondary Outcomes (16)

• Assess emotional state pre- and post-treatment using the PANAS questionnaire.

  Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).

• Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment.

  Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).

• Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments.

  Administered at a pre-treatment visit (at the baseline visit); and at the four post-treatment visits (one week post-treatment, and 3-, 6-, and 9-months post-treatment).

• Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales.

  Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).

• Assess demographics using a self-report assessment

  Administered once at a pre-treatment visit, specifically at the initial screening visit.

Study Arms (4)

THC Group

EXPERIMENTAL

Cannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC)

Drug: Tetrahydrocannabinol

CBD Group

EXPERIMENTAL

Cannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD)

Drug: Cannabidiol

THC & CBD Group

EXPERIMENTAL

Cannabis with 5 mg THC and 5 mg CBD; up to a maximum of 5 doses/day (max doses = 25 mg THC and 25 mg CBD)

Drug: Tetrahydrocannabinol; Drug: Cannabidiol

Placebo Group

ACTIVE COMPARATOR

Cannabis with \<1mg THC and \<1mg CBD; up to a maximum of 5 doses/day (max dose = \<5 mg THC and \<5 mg CBD)

Drug: Placebo

Interventions

Tetrahydrocannabinol DRUG

Plant cannabis that will be smoked

Also known as: THC

THC & CBD Group; THC Group

Cannabidiol DRUG

Plant cannabidiol that will be smoked

Also known as: CBD

CBD Group; THC & CBD Group

Placebo DRUG

Plant will be smoked.

Placebo Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a healthy veteran who has served in a branch of the US armed forces
• report using cannabis within the past year
• currently meet DSM-5 criteria for PTSD and a score of 25 or greater on the CAPS-5 (the anchor, or index, trauma does not have to be related to military service)
• between the ages of 19-69 years old
• not seeking treatment for Cannabis Use Disorder
• stable (i.e., under the care of a physician or therapist and not experiencing acute symptoms) on psychotropic medications and/or psychotherapy before the study begins (participants can be in treatment for PTSD)
• agree to adhere to study procedures

You may not qualify if:

• pregnant, lactating, or heterosexually active women and not using medically approved birth control
• current or past bipolar or psychotic disorder as determined using the SCID-5
• at immediate high risk for suicide based on the C-SSRS
• current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)
• allergies and/or other contradictions for using cannabis
• any clinically significant medical problems
• systolic/diastolic BP \>140/90 mmHg or systolic BP \<95 mmHg
• elevated liver function tests
• exhibit cognitive impairment (\<80 IQ)
• enrolled in another clinical trial or have received any drug as part of a research study within 30 days of dosing
• used a prescription medication (with the exception of birth control) within 14 days of study entry that in the opinion of the medically responsible investigator will interfere with the safety of the participant or the study results
• unable to provide informed consent

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (53)

• Tashkin DP, Roth MD. Pulmonary effects of inhaled cannabis smoke. Am J Drug Alcohol Abuse. 2019;45(6):596-609. doi: 10.1080/00952990.2019.1627366. Epub 2019 Jul 12.

  PMID: 31298945 BACKGROUND

• Huang YH, Zhang ZF, Tashkin DP, Feng B, Straif K, Hashibe M. An epidemiologic review of marijuana and cancer: an update. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):15-31. doi: 10.1158/1055-9965.EPI-14-1026.

  PMID: 25587109 BACKGROUND

• Taylor DR, Fergusson DM, Milne BJ, Horwood LJ, Moffitt TE, Sears MR, Poulton R. A longitudinal study of the effects of tobacco and cannabis exposure on lung function in young adults. Addiction. 2002 Aug;97(8):1055-61. doi: 10.1046/j.1360-0443.2002.00169.x.

  PMID: 12144608 BACKGROUND

• Tashkin DP, Simmons MS, Sherrill DL, Coulson AH. Heavy habitual marijuana smoking does not cause an accelerated decline in FEV1 with age. Am J Respir Crit Care Med. 1997 Jan;155(1):141-8. doi: 10.1164/ajrccm.155.1.9001303.

  PMID: 9001303 BACKGROUND

• Brauer RW, Dutcher JA, Vorus WS. Effects of prolonged simultaneous exposure of CD-1 mice to high pressures and inert gas narcosis. J Appl Physiol (1985). 1986 Dec;61(6):2129-35. doi: 10.1152/jappl.1986.61.6.2129.

  PMID: 3804920 BACKGROUND

• Baldwin GC, Tashkin DP, Buckley DM, Park AN, Dubinett SM, Roth MD. Marijuana and cocaine impair alveolar macrophage function and cytokine production. Am J Respir Crit Care Med. 1997 Nov;156(5):1606-13. doi: 10.1164/ajrccm.156.5.9704146.

  PMID: 9372683 BACKGROUND

• Tetrault JM, Crothers K, Moore BA, Mehra R, Concato J, Fiellin DA. Effects of marijuana smoking on pulmonary function and respiratory complications: a systematic review. Arch Intern Med. 2007 Feb 12;167(3):221-8. doi: 10.1001/archinte.167.3.221.

  PMID: 17296876 BACKGROUND

• Tashkin DP, Fligiel S, Wu TC, Gong H Jr, Barbers RG, Coulson AH, Simmons MS, Beals TF. Effects of habitual use of marijuana and/or cocaine on the lung. NIDA Res Monogr. 1990;99:63-87. No abstract available.

  PMID: 2267014 BACKGROUND

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

  PMID: 1932883 BACKGROUND

• Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.

  PMID: 660402 BACKGROUND

• Stiglmayr C, Schimke P, Wagner T, Braakmann D, Schweiger U, Sipos V, Fydrich T, Schmahl C, Ebner-Priemer U, Kleindienst N, Bischkopf J, Auckenthaler A, Kienast T. Development and psychometric characteristics of the Dissociation Tension Scale. J Pers Assess. 2010 May;92(3):269-77. doi: 10.1080/00223891003670232.

  PMID: 20408027 BACKGROUND

• Briere, J. (2002). Multiscale Dissociation Inventory Professional Manual. Odessa, Florida: Psychological Assessment Resources.

  BACKGROUND

• Delis DC, Freeland J, Kramer JH, Kaplan E. Integrating clinical assessment with cognitive neuroscience: construct validation of the California Verbal Learning Test. J Consult Clin Psychol. 1988 Feb;56(1):123-30. doi: 10.1037//0022-006x.56.1.123. No abstract available.

  PMID: 3346437 BACKGROUND

• Budney AJ, Novy PL, Hughes JR. Marijuana withdrawal among adults seeking treatment for marijuana dependence. Addiction. 1999 Sep;94(9):1311-22. doi: 10.1046/j.1360-0443.1999.94913114.x.

  PMID: 10615717 BACKGROUND

• Heishman SJ, Evans RJ, Singleton EG, Levin KH, Copersino ML, Gorelick DA. Reliability and validity of a short form of the Marijuana Craving Questionnaire. Drug Alcohol Depend. 2009 Jun 1;102(1-3):35-40. doi: 10.1016/j.drugalcdep.2008.12.010. Epub 2009 Feb 13.

  PMID: 19217724 BACKGROUND

• Woskie SR, Bello A, Rennix C, Jiang L, Trivedi AN, Savitz DA. Burn Pit Exposure Assessment to Support a Cohort Study of US Veterans of the Wars in Iraq and Afghanistan. J Occup Environ Med. 2023 Jun 1;65(6):449-457. doi: 10.1097/JOM.0000000000002788. Epub 2023 Jan 11.

  PMID: 36728333 BACKGROUND

• Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000 Nov 15;152(10):992-1002. doi: 10.1093/aje/152.10.992.

  PMID: 11092441 BACKGROUND

• Knopf, Alison. (2021). NIDA sets 5 mg of THC as standard cannabis unit for research. Alcoholism & Drug Abuse Weekly. 33. 6-7. 10.1002/adaw.33068.

  BACKGROUND

• Lake S, Kerr T, Buxton J, Walsh Z, Marshall BD, Wood E, Milloy MJ. Does cannabis use modify the effect of post-traumatic stress disorder on severe depression and suicidal ideation? Evidence from a population-based cross-sectional study of Canadians. J Psychopharmacol. 2020 Feb;34(2):181-188. doi: 10.1177/0269881119882806. Epub 2019 Nov 5.

  PMID: 31684805 BACKGROUND

• Kimbrel NA, Newins AR, Dedert EA, Van Voorhees EE, Elbogen EB, Naylor JC, Ryan Wagner H, Brancu M; VA Mid-Atlantic MIRECC Workgroup; Beckham JC, Calhoun PS. Cannabis use disorder and suicide attempts in Iraq/Afghanistan-era veterans. J Psychiatr Res. 2017 Jun;89:1-5. doi: 10.1016/j.jpsychires.2017.01.002. Epub 2017 Jan 5.

  PMID: 28129565 BACKGROUND

• Americ, I.a.A.V.o. 2019 Member Survey. Perceptions and views of Iraq and Afghanistan veterans on the challenges and successes of the next greatest generation of veterans. . 2019; Available from: https://iava.org/iavas-2019-member-survey-results/.

  BACKGROUND

• Olenick M, Flowers M, Diaz VJ. US veterans and their unique issues: enhancing health care professional awareness. Adv Med Educ Pract. 2015 Dec 1;6:635-9. doi: 10.2147/AMEP.S89479. eCollection 2015.

  PMID: 26664252 BACKGROUND

• Boden MT, Babson KA, Vujanovic AA, Short NA, Bonn-Miller MO. Posttraumatic stress disorder and cannabis use characteristics among military veterans with cannabis dependence. Am J Addict. 2013 May-Jun;22(3):277-84. doi: 10.1111/j.1521-0391.2012.12018.x.

  PMID: 23617872 BACKGROUND

• Adkisson K, Cunningham KC, Dedert EA, Dennis MF, Calhoun PS, Elbogen EB, Beckham JC, Kimbrel NA. Cannabis Use Disorder and Post-Deployment Suicide Attempts in Iraq/Afghanistan-Era Veterans. Arch Suicide Res. 2019 Oct-Dec;23(4):678-687. doi: 10.1080/13811118.2018.1488638. Epub 2018 Nov 17.

  PMID: 29952737 BACKGROUND

• Hill MN, Bierer LM, Makotkine I, Golier JA, Galea S, McEwen BS, Hillard CJ, Yehuda R. Reductions in circulating endocannabinoid levels in individuals with post-traumatic stress disorder following exposure to the World Trade Center attacks. Psychoneuroendocrinology. 2013 Dec;38(12):2952-61. doi: 10.1016/j.psyneuen.2013.08.004. Epub 2013 Sep 10.

  PMID: 24035186 BACKGROUND

• Hill MN, Miller GE, Ho WS, Gorzalka BB, Hillard CJ. Serum endocannabinoid content is altered in females with depressive disorders: a preliminary report. Pharmacopsychiatry. 2008 Mar;41(2):48-53. doi: 10.1055/s-2007-993211.

  PMID: 18311684 BACKGROUND

• deRoon-Cassini TA, Stollenwerk TM, Beatka M, Hillard CJ. Meet Your Stress Management Professionals: The Endocannabinoids. Trends Mol Med. 2020 Oct;26(10):953-968. doi: 10.1016/j.molmed.2020.07.002. Epub 2020 Aug 28.

  PMID: 32868170 BACKGROUND

• Abizaid A, Merali Z, Anisman H. Cannabis: A potential efficacious intervention for PTSD or simply snake oil? J Psychiatry Neurosci. 2019 Mar 1;44(2):75-78. doi: 10.1503/jpn.190021. No abstract available.

  PMID: 30810022 BACKGROUND

• Zachary RA (1991) Shipley Institute of Living Scale: revised manual. Los Angeles: Western Psychological Services

  BACKGROUND

• First MB, Williams JBW, Karg RS, Spitzer RL (2015) User's Guide for the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5-RV). Arlington, VA, American Psychiatric Association

  BACKGROUND

• Weathers, F.W., et al., The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). 2013, Washington DC: National Center for PTSD.

  BACKGROUND

• Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.

  BACKGROUND

• Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

  PMID: 28493729 BACKGROUND

• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

  PMID: 22193671 BACKGROUND

• Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001 Dec;8(4):443-54. doi: 10.1177/107319110100800409.

  PMID: 11785588 BACKGROUND

• Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.

  BACKGROUND

• Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.

  BACKGROUND

• Wechsler, D. (2009). Wechsler Memory Scale - 4th Edition. Pearson Assessments.

  BACKGROUND

• BERG EA. A simple objective technique for measuring flexibility in thinking. J Gen Psychol. 1948 Jul;39:15-22. doi: 10.1080/00221309.1948.9918159. No abstract available.

  PMID: 18889466 BACKGROUND

• Milner, B. (1963). Effects of different brain lesions on card sorting. Archives of Neurology, 9, 90-100.

  BACKGROUND

• Bechara A, Damasio H, Tranel D, Damasio AR. Deciding advantageously before knowing the advantageous strategy. Science. 1997 Feb 28;275(5304):1293-5. doi: 10.1126/science.275.5304.1293.

  PMID: 9036851 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Frisch, M.B., Cornell, J., Villanueva, M. & Retzlaff, P.J. (1992). Clinical validation of the quality of life inventory: A measure of life satisfaction for treatment planning and outcome assessment. Psychological Assessment, 4, 92-101.

  BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

  PMID: 1798888 BACKGROUND

• Marczylo TH, Lam PM, Nallendran V, Taylor AH, Konje JC. A solid-phase method for the extraction and measurement of anandamide from multiple human biomatrices. Anal Biochem. 2009 Jan 1;384(1):106-13. doi: 10.1016/j.ab.2008.08.040. Epub 2008 Sep 18.

  PMID: 18823934 BACKGROUND

• Haney M, Ward AS, Comer SD, Foltin RW, Fischman MW. Abstinence symptoms following smoked marijuana in humans. Psychopharmacology (Berl). 1999 Feb;141(4):395-404. doi: 10.1007/s002130050849.

  PMID: 10090647 BACKGROUND

• Haney M, Hart CL, Ward AS, Foltin RW. Nefazodone decreases anxiety during marijuana withdrawal in humans. Psychopharmacology (Berl). 2003 Jan;165(2):157-65. doi: 10.1007/s00213-002-1210-3. Epub 2002 Nov 19.

  PMID: 12439626 BACKGROUND

• Bilgin M, Bindila L, Graessler J, Shevchenko A. Quantitative profiling of endocannabinoids in lipoproteins by LC-MS/MS. Anal Bioanal Chem. 2015 Jul;407(17):5125-31. doi: 10.1007/s00216-015-8559-8. Epub 2015 Mar 18.

  PMID: 25782872 BACKGROUND

• Gachet MS, Rhyn P, Bosch OG, Quednow BB, Gertsch J. A quantitiative LC-MS/MS method for the measurement of arachidonic acid, prostanoids, endocannabinoids, N-acylethanolamines and steroids in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Jan 22;976-977:6-18. doi: 10.1016/j.jchromb.2014.11.001. Epub 2014 Nov 18.

  PMID: 25436483 BACKGROUND

• Marczylo TH, Lam PM, Amoako AA, Konje JC. Anandamide levels in human female reproductive tissues: solid-phase extraction and measurement by ultraperformance liquid chromatography tandem mass spectrometry. Anal Biochem. 2010 May 15;400(2):155-62. doi: 10.1016/j.ab.2009.12.025. Epub 2009 Dec 22.

  PMID: 20026294 BACKGROUND

• Watkins BA, Kim J, Kenny A, Pedersen TL, Pappan KL, Newman JW. Circulating levels of endocannabinoids and oxylipins altered by dietary lipids in older women are likely associated with previously identified gene targets. Biochim Biophys Acta. 2016 Nov;1861(11):1693-1704. doi: 10.1016/j.bbalip.2016.07.007. Epub 2016 Jul 22.

  PMID: 27452639 BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Suicide; Marijuana Abuse

Interventions

Dronabinol; Cannabidiol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Leslie Lundahl, PhD

CONTACT

3139931374; llundahl@wayne.med.edu

Paula Qefaliaj, B.S.

CONTACT

2487168321; paulaq@wayne.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: April 24, 2024
• Study Start: September 22, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)