Post Traumatic Stress DisorderNOCNCT05386862
Warrior CARE: Naturalistic Observation and Harm Reduction
A study testing Reduce THC Use in people with Post Traumatic Stress Disorder and Cannabis Use, run by Wayne State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Cannabis Use, Suicide
- What is being tested?
- Reduce THC Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tolan Park Medical Building
Detroit, Michigan, 48201
About this study
Official title: 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).
Read the 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).
- Conditions
- Post Traumatic Stress Disorder, Cannabis Use, Suicide
- Being tested
- Reduce THC Use
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduce THC UseBehavioural
Reducing THC concentrations and increasing CBD to reduce PTSD symptom severity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reduce THC Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Secondary outcomes (9)
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.
Measured: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
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.
Measured: Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Change in California Verbal Learning Test
Verbal memory task that will be used to measure the change in executive function over time.
Measured: Baseline, 3, 6, 12 months post baseline
Change in Wisconsin Card Sort Task
Computer task that will be used to measure the change in executive function over time.
Measured: Baseline, 3, 6, 12 months post baseline
Change in Iowa Gambling Task
Computer task that measure the change in decision making over time.
Measured: Baseline, 3, 6, 12 months post baseline
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.
Measured: Baseline, 3, 6, 12 months post baseline
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.
Measured: Baseline, 3, 6, 12 months post baseline
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.
Measured: Baseline, 3, 6, 12 months post baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start13 Jul 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Why it stopped: This study protocol was revised, which required closing it and submitting a new application. Since recruitment launched for this protocol, no participants were enrolled and run in this study protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Lundahl, Wayne State University
- Investigators
- Leslie Lundahl, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386862
- Sponsor's protocol ID
- Warrior CARE: NOC
- Acronym
- NOC
- Status last verified
- May 2024
- First submitted
- 28 Apr 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olenick M, Flowers M, Diaz VJ. US veterans and their unique issues: enhancing health care professional awareness. Adv Med Educ Pract. 2015 Dec 1;6:635-9. doi: 10.2147/AMEP.S89479. eCollection 2015.
PubMed 26664252Boden MT, Babson KA, Vujanovic AA, Short NA, Bonn-Miller MO. Posttraumatic stress disorder and cannabis use characteristics among military veterans with cannabis dependence. Am J Addict. 2013 May-Jun;22(3):277-84. doi: 10.1111/j.1521-0391.2012.12018.x.
PubMed 23617872Adkisson K, Cunningham KC, Dedert EA, Dennis MF, Calhoun PS, Elbogen EB, Beckham JC, Kimbrel NA. Cannabis Use Disorder and Post-Deployment Suicide Attempts in Iraq/Afghanistan-Era Veterans. Arch Suicide Res. 2019 Oct-Dec;23(4):678-687. doi: 10.1080/13811118.2018.1488638. Epub 2018 Nov 17.
PubMed 29952737Hill MN, Bierer LM, Makotkine I, Golier JA, Galea S, McEwen BS, Hillard CJ, Yehuda R. Reductions in circulating endocannabinoid levels in individuals with post-traumatic stress disorder following exposure to the World Trade Center attacks. Psychoneuroendocrinology. 2013 Dec;38(12):2952-61. doi: 10.1016/j.psyneuen.2013.08.004. Epub 2013 Sep 10.
PubMed 24035186Hill MN, Miller GE, Ho WS, Gorzalka BB, Hillard CJ. Serum endocannabinoid content is altered in females with depressive disorders: a preliminary report. Pharmacopsychiatry. 2008 Mar;41(2):48-53. doi: 10.1055/s-2007-993211.
PubMed 18311684deRoon-Cassini TA, Stollenwerk TM, Beatka M, Hillard CJ. Meet Your Stress Management Professionals: The Endocannabinoids. Trends Mol Med. 2020 Oct;26(10):953-968. doi: 10.1016/j.molmed.2020.07.002. Epub 2020 Aug 28.
PubMed 32868170Abizaid A, Merali Z, Anisman H. Cannabis: A potential efficacious intervention for PTSD or simply snake oil? J Psychiatry Neurosci. 2019 Mar 1;44(2):75-78. doi: 10.1503/jpn.190021. No abstract available.
PubMed 30810022Zachary 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.
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
PubMed 28493729Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001 Dec;8(4):443-54. doi: 10.1177/107319110100800409.
PubMed 11785588Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wayne Warrior CAnnabis Research and Education: Naturalistic Observation and Harm Reduction
- ClinicalTrials.gov ID
- NCT05386862
- Acronym / sponsor ID
- NOC / Warrior CARE: NOC
- Conditions
- Post Traumatic Stress Disorder, Cannabis Use, Suicide
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study protocol was revised, which required closing it and submitting a new application. Since recruitment launched for this protocol, no participants were enrolled and run in this study protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naturalistic Group | No intervention | –This group will followed as they follow their naturalistic cannabis use. |
| THC Reduction Group | Experimental | Behavioral: Reduce THC UseThis 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. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduce THC UseReducing THC concentrations and increasing CBD to reduce PTSD symptom severity | Behavioural | THC Reduction Group |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
Change in Beck Depression Inventory-II
Time frame: 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
Change in California Verbal Learning Test
Time frame: Baseline, 3, 6, 12 months post baseline
Change in Wisconsin Card Sort Task
Time frame: Baseline, 3, 6, 12 months post baseline
Change in Iowa Gambling Task
Time frame: Baseline, 3, 6, 12 months post baseline
Change in General Health Survey (Short form 36)
Time frame: Baseline, 3, 6, 12 months post baseline
Change in Quality of Life Inventory
Time frame: Baseline, 3, 6, 12 months post baseline
Change in Brief Pain Inventory
Time frame: Baseline, 3, 6, 12 months post baseline
Exploratory analysis of genetic markers associated with endocannabinoid system
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 26664252Olenick M, Flowers M, Diaz VJ. US veterans and their unique issues: enhancing health care professional awareness. Adv Med Educ Pract. 2015 Dec 1;6:635-9. doi: 10.2147/AMEP.S89479. eCollection 2015.
- Background: PubMed 23617872Boden MT, Babson KA, Vujanovic AA, Short NA, Bonn-Miller MO. Posttraumatic stress disorder and cannabis use characteristics among military veterans with cannabis dependence. Am J Addict. 2013 May-Jun;22(3):277-84. doi: 10.1111/j.1521-0391.2012.12018.x.
- Background: PubMed 29952737Adkisson K, Cunningham KC, Dedert EA, Dennis MF, Calhoun PS, Elbogen EB, Beckham JC, Kimbrel NA. Cannabis Use Disorder and Post-Deployment Suicide Attempts in Iraq/Afghanistan-Era Veterans. Arch Suicide Res. 2019 Oct-Dec;23(4):678-687. doi: 10.1080/13811118.2018.1488638. Epub 2018 Nov 17.
- Background: PubMed 24035186Hill MN, Bierer LM, Makotkine I, Golier JA, Galea S, McEwen BS, Hillard CJ, Yehuda R. Reductions in circulating endocannabinoid levels in individuals with post-traumatic stress disorder following exposure to the World Trade Center attacks. Psychoneuroendocrinology. 2013 Dec;38(12):2952-61. doi: 10.1016/j.psyneuen.2013.08.004. Epub 2013 Sep 10.
- Background: PubMed 18311684Hill MN, Miller GE, Ho WS, Gorzalka BB, Hillard CJ. Serum endocannabinoid content is altered in females with depressive disorders: a preliminary report. Pharmacopsychiatry. 2008 Mar;41(2):48-53. doi: 10.1055/s-2007-993211.
- Background: PubMed 32868170deRoon-Cassini TA, Stollenwerk TM, Beatka M, Hillard CJ. Meet Your Stress Management Professionals: The Endocannabinoids. Trends Mol Med. 2020 Oct;26(10):953-968. doi: 10.1016/j.molmed.2020.07.002. Epub 2020 Aug 28.
- Background: PubMed 30810022Abizaid A, Merali Z, Anisman H. Cannabis: A potential efficacious intervention for PTSD or simply snake oil? J Psychiatry Neurosci. 2019 Mar 1;44(2):75-78. doi: 10.1503/jpn.190021. No abstract available.
- BackgroundZachary RA (1991) Shipley Institute of Living Scale: revised manual. Los Angeles: Western Psychological Services
- BackgroundFirst 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
- BackgroundWeathers, F.W., et al., The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). 2013, Washington DC: National Center for PTSD.
- BackgroundWeathers, 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.
- Background: PubMed 28493729Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Lundahl, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduce THC Use in people with Post Traumatic Stress Disorder and Cannabis Use, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5) (time frame: Baseline, 3, 6, 12 months post baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386862, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.