Warrior CARE: Cannabis Behavioral Health (NCT06381180) | Clinical Trial Compass
RecruitingPhase 1/2
Warrior CARE: Cannabis Behavioral Health
United States500 participantsStarted 2025-09-22
Plain-language summary
This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.
Who can participate
Age range
19 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 inves…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
2
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
3
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).
4
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
5
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