Cannabis Use, Post Traumatic Stress Disorder, Suicide
Conditions
Brief summary
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
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).
Interventions
BEHAVIORALReduce THC Use
Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity
Sponsors
Wayne State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5) | Baseline, 3, 6, 12 months post baseline | 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. |
| Change in Post-Traumatic Stress Disorder Symptom Checklist for DSM-5 (PCL-5) | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | 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. |
| Change in Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline, 3, 6, 12 months post baseline | 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. |
| Change in Suicide Behavior Questionnaire - Revised (SBQ-R) | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | Suicide ideation, intensity, and behavior assessment completed by participants. Scores range from 3 to 18, with lower score representing better study outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Iowa Gambling Task | Baseline, 3, 6, 12 months post baseline | Computer task that measure the change in decision making over time. |
| Change in General Health Survey (Short form 36) | Baseline, 3, 6, 12 months post baseline | 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. |
| Change in Beck Depression Inventory-II | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | Self report depression checklist. Beck Depression Inventory-II scores range from 0 to 63 and lower score represent better outcome. |
| Change in Brief Pain Inventory | Baseline, 3, 6, 12 months post baseline | 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. |
| Exploratory analysis of genetic markers associated with endocannabinoid system | Baseline | 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. |
| Change in Quality of Life Inventory | Baseline, 3, 6, 12 months post baseline | 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. |
| Change in State Trait Anxiety Inventory Form Y | Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline | Anxiety symptom checklists ranging from from 20 to 80. Lower scores on this measures represents better study outcome. |
| Change in California Verbal Learning Test | Baseline, 3, 6, 12 months post baseline | Verbal memory task that will be used to measure the change in executive function over time. |
| Change in Wisconsin Card Sort Task | Baseline, 3, 6, 12 months post baseline | Computer task that will be used to measure the change in executive function over time. |
Countries
United States
Outcome results
None listed