protocolSection identificationModule nctId: NCT06381180, orgStudyIdInfo id: Warrior CARE: CBH, briefTitle: Warrior CARE: Cannabis Behavioral Health, acronym: CBH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Wayne State University, class: OTHER, descriptionModule briefSummary: This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: Cannabis Use, conditions: Suicide, conditions: Veterans, conditions: Marijuana, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Tetrahydrocannabinol, interventions name: Cannabidiol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment., primaryOutcomes measure: Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment, primaryOutcomes measure: Assessing Suicidality over time using the C-SSRS assessment., primaryOutcomes measure: Assessing Suicidality throughout the study using the SBQ-R assessment., primaryOutcomes measure: Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires., secondaryOutcomes measure: Assess emotional state pre- and post-treatment using the PANAS questionnaire., secondaryOutcomes measure: Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment., secondaryOutcomes measure: Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires., secondaryOutcomes measure: Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments., secondaryOutcomes measure: Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales., secondaryOutcomes measure: Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires., secondaryOutcomes measure: Assess demographics using a self-report assessment, secondaryOutcomes measure: Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments., secondaryOutcomes measure: Assess smoking habits and history using the FTND assessment, secondaryOutcomes measure: Assess general health and history pre- and post-treatment using the SF-36 assessment., secondaryOutcomes measure: Assess healthcare utilization throughout the study., secondaryOutcomes measure: Assess pain pre- and post-treatment using the BPI assessment., secondaryOutcomes measure: Assess sleepiness pre- and post-treatment using the ESS questionnaire., secondaryOutcomes measure: Assess overall quality of life pre- and post-treatment using the QOL questionnaire., secondaryOutcomes measure: Assess substance use throughout the study using the TLFB assessment., secondaryOutcomes measure: Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks, secondaryOutcomes measure: Assess physiological measures throughout the study as a safety check, secondaryOutcomes measure: Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD., eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wayne State University, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: Nareen Sadik, B.S., role: CONTACT, geoPoint lat: 42.33143, lon: -83.04575, hasResults: False