Warrior CARE: Naturalistic Observation and Harm Reduction

Study Overview
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Brief Summary
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This study is looking at therapeutic potential of reducing Tetrahydrocannabinol (THC) levels in regular cannabis smokers using contingency management (CM) intervention in a U.S. veteran population with post-traumatic stress disorder (PTSD).

Detailed Description
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In this trial, the investigators will recruit veterans with post-traumatic stress disorder (PTSD) who report using cannabis. Veterans will be assigned (via participant self-selection) into either a naturalistic group that will be followed as the participants continue to use cannabis as they normally do (observation only), or into a THC (tetrahydrocannabinol) reduction group in which veterans are asked to switch from their typical cannabis product to using a lower THC/higher Cannabidiol (CBD) product; adherence to this switch will be incentivized using a behavioral intervention called contingency management (CM).

Official Title
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Wayne Warrior CAnnabis Research and Education: Naturalistic Observation and Harm Reduction

Conditions
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Post Traumatic Stress Disorder, Cannabis Use, Suicide

Intervention / Treatment
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* Behavioral: Reduce THC Use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to provide informed consent, IQ Score >80, served in branch of the US armed forces, report using cannabis, report using cannabis (at least 4x/month) test positive for THC in urine drug screen, meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration Exclusion Criteria: urine drug screen positive for any other drugs 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, Alcohol (mild or moderate) and Cannabis Use Disorder seeking treatment for Cannabis Use Disorder

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Naturalistic Group<br>This group will followed as they follow their naturalistic cannabis use. | |
| Experimental: THC Reduction Group<br>This group will be asked to reduce the THC content and increase CBD content of their cannabis products to study the effect of PTSD symptom severity. | Behavioral: Reduce THC Use<br>* Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5) | Assessing change in PTSD symptom severity from baseline, to 3, 6, and 12 months post baseline. A decrease in the CAPS-5 assessment indicates less PTSD symptoms endorsed and a better outcome. Minimum score is 0, maximum score is 20 for PTSD subtotals. | Baseline, 3, 6, 12 months post baseline | 
| Change in Post-Traumatic Stress Disorder Symptom Checklist for DSM-5 (PCL-5) | Assessing change in PTSD symptom and severity over time. This scale is completed by the participants and a lower score indicates less PTSD symptoms and better study outcomes. Maximum score is 80 and minimum score is 20. | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | 
| Change in Columbia Suicide Severity Rating Scale (C-SSRS) | Suicide ideation, intensity, and behavior assessment. This is a clinical interview to assess suicide severity. Reduction in suicide related behaviors represents a better study outcome. | Baseline, 3, 6, 12 months post baseline | 
| Change in Suicide Behavior Questionnaire - Revised (SBQ-R) | Suicide ideation, intensity, and behavior assessment completed by participants. Scores range from 3 to 18, with lower score representing better study outcome. | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beck Depression Inventory-II | Self report depression checklist. Beck Depression Inventory-II scores range from 0 to 63 and lower score represent better outcome. | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | 
| Change in State Trait Anxiety Inventory Form Y | Anxiety symptom checklists ranging from from 20 to 80. Lower scores on this measures represents better study outcome. | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | 
| Change in California Verbal Learning Test | Verbal memory task that will be used to measure the change in executive function over time. | Baseline, 3, 6, 12 months post baseline | 
| Change in Wisconsin Card Sort Task | Computer task that will be used to measure the change in executive function over time. | Baseline, 3, 6, 12 months post baseline | 
| Change in Iowa Gambling Task | Computer task that measure the change in decision making over time. | Baseline, 3, 6, 12 months post baseline | 
| Change in General Health Survey (Short form 36) | General health questionnaire to assess change in general health outcomes over time. General health survey is scored from 0 to 100 with a higher score denoting better study outcomes. | Baseline, 3, 6, 12 months post baseline | 
| Change in Quality of Life Inventory | Quality of Life assessment to examine change in quality of life over time. Quality of life inventory is scored from 16 to 112, higher score indicating better study outcome. | Baseline, 3, 6, 12 months post baseline | 
| Change in Brief Pain Inventory | Brief pain inventory asks participants identify areas on their body causing pain and rate the severity. Less pain symptoms over time represent a better study outcome. | Baseline, 3, 6, 12 months post baseline | 
| Exploratory analysis of genetic markers associated with endocannabinoid system | DNA analysis to examine genetic markers associated with the endocannabinoid system. The genetic data will be collected from blood samples during baseline. Data will be grouped based on genetic variants of proteins within the endocannabinoid system to identify genetic differences in response to the treatment trial. | Baseline |