Clinical trial NCT05386862: Warrior CARE: Naturalistic Observation and Harm Reduction
Official title: Wayne Warrior CAnnabis Research and Education: Naturalistic Observation and Harm Reduction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Cannabis Use
Suicide
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5)
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in Post-Traumatic Stress Disorder Symptom Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
measure: Change in Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in Suicide Behavior Questionnaire - Revised (SBQ-R)
timeFrame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Secondary outcomes:
measure: Change in Beck Depression Inventory-II
timeFrame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
measure: Change in State Trait Anxiety Inventory Form Y
timeFrame: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
measure: Change in California Verbal Learning Test
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in Wisconsin Card Sort Task
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in Iowa Gambling Task
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in General Health Survey (Short form 36)
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in Quality of Life Inventory
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Change in Brief Pain Inventory
timeFrame: Baseline, 3, 6, 12 months post baseline
measure: Exploratory analysis of genetic markers associated with endocannabinoid system
timeFrame: Baseline
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Tolan Park Medical Building
state: Michigan
Study officials:
affiliation: Wayne State University
name: Leslie Lundahl, PhD
role: PRINCIPAL_INVESTIGATOR
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