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Warrior CARE: Naturalistic Observation and Harm Reduction (NOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05386862
Recruitment Status : Recruiting
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Leslie Lundahl, Wayne State University

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).

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Cannabis Use Suicide Behavioral: Reduce THC Use Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wayne Warrior CAnnabis Research and Education: Naturalistic Observation and Harm Reduction
Estimated Study Start Date : May 25, 2022
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386862


Contacts
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Contact: Klevis Study Coordinator, MS 3139933960 kkaravidha@wayne.edu
Contact: Reshma Research Assistant, BS 3139933966 hk0015@wayne.edu

Locations
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United States, Michigan
Tolan Park Medical Building Recruiting
Detroit, Michigan, United States, 48201
Contact: Klevis Research Coordinator, MS         
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Leslie Lundahl, PhD Wayne State University
Publications:
Zachary RA (1991) Shipley Institute of Living Scale: revised manual. Los Angeles: Western Psychological Services
First MB, Williams JBW, Karg RS, Spitzer RL (2015) User's Guide for the Structured Clinical Interview for DSM-5 Disorders, Research Version (SCID-5-RV). Arlington, VA, American Psychiatric Association
Weathers, F.W., et al., The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). 2013, Washington DC: National Center for PTSD.
Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
Wechsler, D. (2009). Wechsler Memory Scale - 4th Edition. Pearson Assessments.
Milner, B. (1963). Effects of different brain lesions on card sorting. Archives of Neurology, 9, 90-100.
Frisch, M.B., Cornell, J., Villanueva, M. & Retzlaff, P.J. (1992). Clinical validation of the quality of life inventory: A measure of life satisfaction for treatment planning and outcome assessment. Psychological Assessment, 4, 92-101.

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Responsible Party: Leslie Lundahl, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT05386862    
Other Study ID Numbers: Warrior CARE: NOC
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Stress Disorders, Traumatic
Suicide
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms
Substance-Related Disorders
Chemically-Induced Disorders