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Warrior CARE: Naturalistic Observation and Harm Reduction (NOC)

Primary Purpose

Post Traumatic Stress Disorder, Cannabis Use, Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduce THC Use
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tolan Park Medical BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Naturalistic Group

THC Reduction Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
Change in State Trait Anxiety Inventory Form Y
Anxiety symptom checklists ranging from from 20 to 80. Lower scores on this measures represents better study outcome.
Change in California Verbal Learning Test
Verbal memory task that will be used to measure the change in executive function over time.
Change in Wisconsin Card Sort Task
Computer task that will be used to measure the change in executive function over time.
Change in Iowa Gambling Task
Computer task that measure the change in decision making over time.
Change in General Health Survey (Short form 36)
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 Quality of Life Inventory
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 Brief Pain Inventory
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
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.

Full Information

First Posted
April 28, 2022
Last Updated
May 17, 2022
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT05386862
Brief Title
Warrior CARE: Naturalistic Observation and Harm Reduction
Acronym
NOC
Official Title
Wayne Warrior CAnnabis Research and Education: Naturalistic Observation and Harm Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Cannabis Use, Suicide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
215 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naturalistic Group
Arm Type
No Intervention
Arm Description
This group will followed as they follow their naturalistic cannabis use.
Arm Title
THC Reduction Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reduce THC Use
Intervention Description
Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity
Primary Outcome Measure Information:
Title
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5)
Description
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
Title
Change in Post-Traumatic Stress Disorder Symptom Checklist for DSM-5 (PCL-5)
Description
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
Title
Change in Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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
Title
Change in Suicide Behavior Questionnaire - Revised (SBQ-R)
Description
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 Outcome Measure Information:
Title
Change in Beck Depression Inventory-II
Description
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
Title
Change in State Trait Anxiety Inventory Form Y
Description
Anxiety symptom checklists ranging from from 20 to 80. Lower scores on this measures represents better study outcome.
Time Frame
Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Title
Change in California Verbal Learning Test
Description
Verbal memory task that will be used to measure the change in executive function over time.
Time Frame
Baseline, 3, 6, 12 months post baseline
Title
Change in Wisconsin Card Sort Task
Description
Computer task that will be used to measure the change in executive function over time.
Time Frame
Baseline, 3, 6, 12 months post baseline
Title
Change in Iowa Gambling Task
Description
Computer task that measure the change in decision making over time.
Time Frame
Baseline, 3, 6, 12 months post baseline
Title
Change in General Health Survey (Short form 36)
Description
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.
Time Frame
Baseline, 3, 6, 12 months post baseline
Title
Change in Quality of Life Inventory
Description
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.
Time Frame
Baseline, 3, 6, 12 months post baseline
Title
Change in Brief Pain Inventory
Description
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.
Time Frame
Baseline, 3, 6, 12 months post baseline
Title
Exploratory analysis of genetic markers associated with endocannabinoid system
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klevis Study Coordinator, MS
Phone
3139933960
Email
kkaravidha@wayne.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Reshma Research Assistant, BS
Phone
3139933966
Email
hk0015@wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Lundahl, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tolan Park Medical Building
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klevis Research Coordinator, MS

12. IPD Sharing Statement

Plan to Share IPD
No
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Warrior CARE: Naturalistic Observation and Harm Reduction

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