Warrior CARE: Naturalistic Observation and Harm Reduction

Wayne State University

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Post Traumatic Stress Disorder Cannabis Use Suicide

Interventions

Reduce THC UseBEHAVIORAL

Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity

Eligibility

Sex: ALLMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Tolan Park Medical Building

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline

Secondary Outcomes

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.

Time frame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline

Change in State Trait Anxiety Inventory Form Y

Data from ClinicalTrials.gov

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