Warrior CARE: Cannabis Behavioral Health for Veterans with PTSD
This study is for veterans aged 19-69 who have Post Traumatic Stress Disorder (PTSD) and use cannabis, or are interested in trying it for symptom relief. It aims to see if smoking specific cannabis plants, Tetrahydrocannabinol (THC) or Cannabidiol (CBD), can help with PTSD symptoms and suicidal thoughts. You would be randomly assigned to one of four groups: THC, CBD, a combination of both, or a placebo (an inactive substance). The study will measure changes in your PTSD diagnosis and symptoms using questionnaires, and also track suicidal thoughts over time. The study is currently unclear on its recruitment status and plans to enroll 500 participants.
- Study design
- This is a randomized, controlled clinical trial involving 500 participants. You would be assigned to one of four groups: THC, CBD, THC+CBD, or a placebo.
- What's involved
- You would smoke your assigned cannabis dose daily for 12 weeks. You will also complete weekly questionnaires and attend pre-treatment, weekly treatment, and post-treatment visits for up to 9 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have follow-up visits one week, 3 months, 6 months, and 9 months after the 12-week treatment phase.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Warrior CARE: Cannabis Behavioral Health
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
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What this trial measures
- Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.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).
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.
- Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessmentAdministered 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
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.
- Assessing Suicidality over time using the C-SSRS assessment.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).
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.
- Assessing Suicidality throughout the study using the SBQ-R assessment.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
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.
- Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires.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
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).