Warrior CARE: Cannabis Behavioral Health
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-69
SponsorWayne State University
About this trial
This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Tetrahydrocannabinol
DrugPlant cannabis that will be smoked
Cannabidiol
DrugPlant cannabidiol that will be smoked
Placebo
DrugPlant will be smoked.
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: THC GroupExperimental treatment 1 intervention
Group B: CBD GroupExperimental treatment 1 intervention
Group C: THC & CBD GroupExperimental treatment 2 interventions
Group D: Placebo GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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
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.
Time frame
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-months3
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.
Time frame
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.
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.
Time frame
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-monthsSecondary outcomes
1
Assess emotional state pre- and post-treatment using the PANAS questionnaire.
The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire, widely used measure of emotional state, which has excellent psychometric properties.
Time frame
Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).2
Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment.
The UCLA Three-Item Loneliness Scale (3-ILS) assesses social isolation and feelings of loneliness.
Time frame
Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).3
Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments.
The Multiscale Dissociation Inventory (MDI) is a self-report questionnaire of dissociative symptomatology over the past month. The Dissociation Tension Scale (DSS) is a self-report measure of dissociative symptoms sensitive to weekly changes.
Time frame
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).4
Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales.
The Subjective Cannabis Effects Rating Form (SCERF) will ask participants to complete a Visual Analog Scale (VAS) of "good drug effect," "bad drug effect," "strength of drug effect," liking," "sedated," and "desire to take again" and indicate whether they thought they received active drug or placebo. The Subjective Effects Scale (SES) VAS is a 33-item scale which includes the phrase "I feel…" followed by adjectives describing a mood (e.g., "anxious", "friendly," "down," etc.), a drug effect (e.g., "high," "stimulated", "a good drug effect") or a physical symptom (e.g., "hungry," "tired," "restless").
Time frame
Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).Sponsors and contacts
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Source ClinicalTrials.gov