Warrior CARE: Naturalistic Observation and Harm Reduction

NCT05386862 | Withdrawn

• 1 other identifier: Warrior CARE: NOC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder; Cannabis Use; Suicide

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change in Beck Depression Inventory-II

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

• Change in State Trait Anxiety Inventory Form Y

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

• Change in California Verbal Learning Test

  Baseline, 3, 6, 12 months post baseline

• Change in Wisconsin Card Sort Task

  Baseline, 3, 6, 12 months post baseline

• Change in Iowa Gambling Task

  Baseline, 3, 6, 12 months post baseline

Study Arms (2)

Naturalistic Group

NO INTERVENTION

This group will followed as they follow their naturalistic cannabis use.

THC Reduction Group

EXPERIMENTAL

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

Interventions

Reduce THC Use BEHAVIORAL

Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity

THC Reduction Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Suicide

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Leslie Lundahl, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 23, 2022
• Study Start: July 13, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)