Clinical trial NCT06381180: Warrior CARE: Cannabis Behavioral Health
Official title: Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Post Traumatic Stress Disorder
Cannabis Use
Suicide
Veterans
Marijuana
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: In this clinical trial, we will recruit veterans with PTSD who report using cannabis or have interest in trying cannabis for symptom relief. Veterans will be randomized into one of four different groups: THC (∆9-tetrahydrocannabinol), CBD (cannabidiol), THC+CBD, and Placebo, and undergo a 12-week treatment phase where they will be asked to vaporize their assigned cannabis dose every day for 12 weeks. Participants will complete weekly questionnaires regarding their mood, behavior and drug consumption. Furthermore, there is a laboratory component that will assess cognition, fear conditioning, and other PTSD-related measures.

Eligibility criteria: Inclusion Criteria:

* able to provide informed consent, IQ Score \>80,
* served in branch of the US armed forces, report using cannabis,
* report using cannabis (no more than 2x in last month and no more than 100 lifetime use episodes)
* meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration

Exclusion Criteria:

* urine drug screen positive for any other drugs
* systolic/diastolic BP \>140/90 mmHg?
* any clinically significant medical problems,
* any current or past serious psychotic or bipolar disorder diagnosis as determined by 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)
* pregnancy, lactating
* unable to provide informed consent

Primary outcomes:
measure: Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.
timeFrame: 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).
measure: Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment
timeFrame: 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
measure: Assessing Suicidality over time using the C-SSRS assessment.
timeFrame: 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).
measure: Assessing Suicidality throughout the study using the SBQ-R assessment.
timeFrame: 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
measure: Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires.
timeFrame: 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:
measure: Assess emotional state pre- and post-treatment using the PANAS questionnaire.
timeFrame: Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).
measure: Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment.
timeFrame: Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).
measure: Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires.
timeFrame: Administered once at a pre-treatment visit, specifically at the baseline visit.
measure: Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments.
timeFrame: Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).
measure: Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales.
timeFrame: Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).
measure: Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires.
timeFrame: Administered at a pre-treatment visit (at the baseline visit); and the first post-treatment visit (one week post-treatment).
measure: Assess demographics using a self-report assessment
timeFrame: Administered once at a pre-treatment visit, specifically at the initial screening visit.
measure: Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments.
timeFrame: Administered once at a pre-treatment visit, specifically at the baseline visit.
measure: Assess smoking habits and history using the FTND assessment
timeFrame: Administered once at a pre-treatment visit, specifically at the baseline visit.
measure: Assess general health and history pre- and post-treatment using the SF-36 assessment.
timeFrame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
measure: Assess healthcare utilization throughout the study.
timeFrame: Administered at both pre-treatment visits (the initial screening and baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
measure: Assess pain pre- and post-treatment using the BPI assessment.
timeFrame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
measure: Assess sleepiness pre- and post-treatment using the ESS questionnaire.
timeFrame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
measure: Assess overall quality of life pre- and post-treatment using the QOL questionnaire.
timeFrame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
measure: Assess substance use throughout the study using the TLFB assessment.
timeFrame: 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
measure: Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks
timeFrame: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
measure: Assess physiological measures throughout the study as a safety check
timeFrame: 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
measure: Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD.
timeFrame: Biological samples will be collected at a pre-treatment (at the baseline visit); during the 12-week treatment phase (every two weeks during the treatment phase); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months po
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
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