Warrior CARE: Naturalistic Observation and Harm Reduction (NOC)

May 1, 2024 updated by: Leslie Lundahl, Wayne State University

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Tolan Park Medical Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Naturalistic Group
This group will followed as they follow their naturalistic cannabis use.
Experimental: THC Reduction Group
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
Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5)
Time Frame: 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.
Baseline, 3, 6, 12 months post baseline
Change in Post-Traumatic Stress Disorder Symptom Checklist for DSM-5 (PCL-5)
Time Frame: 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.
Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Change in Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
Baseline, 3, 6, 12 months post baseline
Change in Suicide Behavior Questionnaire - Revised (SBQ-R)
Time Frame: 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.
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
Time Frame: 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.
Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Change in State Trait Anxiety Inventory Form Y
Time Frame: 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.
Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Change in California Verbal Learning Test
Time Frame: Baseline, 3, 6, 12 months post baseline
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
Time Frame: Baseline, 3, 6, 12 months post baseline
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
Time Frame: Baseline, 3, 6, 12 months post baseline
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)
Time Frame: 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.
Baseline, 3, 6, 12 months post baseline
Change in Quality of Life Inventory
Time Frame: 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.
Baseline, 3, 6, 12 months post baseline
Change in Brief Pain Inventory
Time Frame: 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.
Baseline, 3, 6, 12 months post baseline
Exploratory analysis of genetic markers associated with endocannabinoid system
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Principal Investigator: Leslie Lundahl, PhD, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Actual)

January 25, 2024

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Estimated)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Warrior CARE: NOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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