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Post Traumatic Stress DisorderPhase 1/2CBHNCT06381180

Warrior CARE: Cannabis Behavioral Health

A Phase 1/2 study testing Tetrahydrocannabinol and Cannabidiol in people with Post Traumatic Stress Disorder and Cannabis Use, run by Wayne State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation. Read more about this study

Who is it for?
Ages 19 to 69 years
What is being tested?
Tetrahydrocannabinol and Cannabidiol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
1 siteUnited States
Study dates
22 Sep 2025to 31 Dec 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • a healthy veteran who has served in a branch of the US armed forces
  • report using cannabis within the past year
  • currently meet DSM-5 criteria for PTSD and a score of 25 or greater on the CAPS-5 (the anchor, or index, trauma does not have to be related to military service)
  • between the ages of 19-69 years old
  • not seeking treatment for Cannabis Use Disorder
  • stable (i.e., under the care of a physician or therapist and not experiencing acute symptoms) on psychotropic medications and/or psychotherapy before the study begins (participants can be in treatment for PTSD)
  • agree to adhere to study procedures

Who cannot join

  • pregnant, lactating, or heterosexually active women and not using medically approved birth control
  • current or past bipolar or psychotic disorder as determined using the SCID-5
  • at immediate high risk for suicide based on the C-SSRS
  • current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)
  • allergies and/or other contradictions for using cannabis
  • any clinically significant medical problems
Show all 12Show fewer
  • systolic/diastolic BP >140/90 mmHg or systolic BP <95 mmHg
  • elevated liver function tests
  • exhibit cognitive impairment (<80 IQ)
  • enrolled in another clinical trial or have received any drug as part of a research study within 30 days of dosing
  • used a prescription medication (with the exception of birth control) within 14 days of study entry that in the opinion of the medically responsible investigator will interfere with the safety of the participant or the study results
  • unable to provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leslie Lundahl, PhD contact

3139931374

llundahl@wayne.med.edu

Paula Qefaliaj, B.S. contact

2486881251

paulaq@wayne.edu

United States1 site, 1 recruiting

  • Wayne State University

    Detroit, Michigan, 48201

    Paula Qefaliaj, B.S., 2486881251, paulaq@wayne.edu

    Recruiting

Other trials in United States

About this study

Official title: Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

Read the detailed description

In this clinical trial, we will recruit veterans with PTSD who report using cannabis or have interest in trying cannabis for symptom relief. Veterans will be randomized into one of four different groups: THC (∆9-tetrahydrocannabinol), CBD (cannabidiol), THC+CBD, and Placebo, and undergo a 12-week treatment phase where they will be asked to smoke their assigned cannabis dose every day for 12 weeks. Participants will complete weekly questionnaires regarding their mood, behavior and drug consumption. Furthermore, there is a laboratory component that will assess cognition, fear conditioning, and other PTSD-related measures.

Being tested
Tetrahydrocannabinol, Cannabidiol, Placebo
Medical subject headings
Stress Disorders, Post-Traumatic, Suicide, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TetrahydrocannabinolDrug

    Also called THC

    Plant cannabis that will be smoked

  • CannabidiolDrug

    Also called CBD

    Plant cannabidiol that will be smoked

  • PlaceboDrug

    Plant will be smoked.

Study groups in NCT06381180
Study groupRoleWhat they receive
THC GroupExperimentalCannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC)
Receives: Drug: Tetrahydrocannabinol
CBD GroupExperimentalCannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD)
Receives: Drug: Cannabidiol
THC & CBD GroupExperimentalCannabis with 5 mg THC and 5 mg CBD; up to a maximum of 5 doses/day (max doses = 25 mg THC and 25 mg CBD)
Receives: Drug: Tetrahydrocannabinol; Drug: Cannabidiol
Placebo GroupActive comparatorCannabis with <1mg THC and <1mg CBD; up to a maximum of 5 doses/day (max dose = <5 mg THC and <5 mg CBD)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.

    PTSD diagnosis will be assessed using the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5 Total Severity Score, a well-validated, semi-structured clinician interview that determines the presence and severity of PTSD symptoms and diagnosis consistent with the DSM-5 and allows for assessing changes in symptom severity over time.

    Measured: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  2. Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment

    The PCL-5 is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD. The PCL-5 is used to monitor symptom change during and after treatment, screen individuals for PTSD, and make a provisional PTSD diagnosis. This assessment will also be used as a safety measure at all visits by assessing PTSD symptom severity.

    Measured: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

  3. Assessing Suicidality over time using the C-SSRS assessment.

    The Columbia Suicide Severity Rating Scale (C-SSRS) is a clinician-administered interview assessing suicidal thoughts and behaviors over time. A baseline form is used to assess lifetime suicidal ideation, intensity, and behavior, and can be compared to current suicidal ideation and intensity assessed over the clinical trial.

    Measured: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  4. Assessing Suicidality throughout the study using the SBQ-R assessment.

    The Suicide Behavior Questionnaire-Revised (SBQ-R) is a brief (4-item), self-administered questionnaire that taps into four dimensions of suicidality (lifetime ideation/attempt, frequency of recent ideation, risk of suicide attempt and self-reported likelihood of future suicidal behavior). This assessment will also be used as a safety measure at all visits by assessing suicidality.

    Measured: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

  5. Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires.

    The Beck Depression Inventory-II (BDI-II) is a self-report depression checklist which assesses neurovegetative depressive symptoms. One item asks specifically about suicidal thoughts and will also be checked at every study visit as a safety measure. The State Trait Anxiety Inventory-Form Y (STAI-Y) is a 40-item questionnaire with two scales assessing state and trait anxiety (somatic and cognitive symptoms).

    Measured: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

Secondary outcomes (16)

  1. Assess emotional state pre- and post-treatment using the PANAS questionnaire.

    The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire, widely used measure of emotional state, which has excellent psychometric properties.

    Measured: Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).

  2. Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment.

    The UCLA Three-Item Loneliness Scale (3-ILS) assesses social isolation and feelings of loneliness.

    Measured: Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).

  3. Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments.

    The Multiscale Dissociation Inventory (MDI) is a self-report questionnaire of dissociative symptomatology over the past month. The Dissociation Tension Scale (DSS) is a self-report measure of dissociative symptoms sensitive to weekly changes.

    Measured: Administered at a pre-treatment visit (at the baseline visit); and at the four post-treatment visits (one week post-treatment, and 3-, 6-, and 9-months post-treatment).

  4. Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales.

    The Subjective Cannabis Effects Rating Form (SCERF) will ask participants to complete a Visual Analog Scale (VAS) of "good drug effect," "bad drug effect," "strength of drug effect," liking," "sedated," and "desire to take again" and indicate whether they thought they received active drug or placebo. The Subjective Effects Scale (SES) VAS is a 33-item scale which includes the phrase "I feel…" followed by adjectives describing a mood (e.g., "anxious", "friendly," "down," etc.), a drug effect (e.g., "high," "stimulated", "a good drug effect") or a physical symptom (e.g., "hungry," "tired," "restless").

    Measured: Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).

  5. Assess demographics using a self-report assessment

    Participants will be asked to complete a personal history form to assess age, gender, sex, gender identity, marital status, race/ethnicity, education, employment status, and annual income.

    Measured: Administered once at a pre-treatment visit, specifically at the initial screening visit.

  6. Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments.

    The Kansas Gulf War Illness Criteria (KGWIC) and the Burn Pit Exposure (BPE) are self-report questionnaires that contain items on toxicants commonly experienced as well as burn pit exposure during war.

    Measured: Administered once at a pre-treatment visit, specifically at the baseline visit.

  7. Assess smoking habits and history using the FTND assessment

    Subjects who smoke cigarettes will also complete the Fagerstrom Test for Nicotine Dependence (FTND) survey to assess smoking history and habits.

    Measured: Administered once at a pre-treatment visit, specifically at the baseline visit.

  8. Assess general health and history pre- and post-treatment using the SF-36 assessment.

    The Short Form 36 (SF-36) is a brief measure of overall self-reported health that is associated with other objective health measures. Scores will be examined to assess change in general health outcomes over time.

    Measured: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  9. Assess healthcare utilization throughout the study.

    The Healthcare Utilization (HU) survey will also assess the number of times participants utilize emergency room, urgent care, specialist, and general practitioner services.

    Measured: Administered at both pre-treatment visits (the initial screening and baseline visit); and at two post-treatment visits (one week post-treatment and 3-months post-treatment visits).

  10. Assess pain pre- and post-treatment using the BPI assessment.

    The Brief Pain Inventory (BPI) asks participants to identify areas on their body causing pain and rate the severity.

    Measured: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  11. Assess sleepiness pre- and post-treatment using the ESS questionnaire.

    The Epworth Sleepiness Scale (ESS) is a self-report questionnaire that will be used to assess daytime sleepiness, which is indicative of sleep problems.

    Measured: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  12. Assess overall quality of life pre- and post-treatment using the QOL questionnaire.

    The Quality of Life (QOL) inventory assesses satisfaction in 17 life areas (work, health, recreation, goals, etc.) and will be used to assess the quality of life changes.

    Measured: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  13. Assess substance use throughout the study using the TLFB assessment.

    The Timeline Follow-Back (TLFB) will be used to record the time of cannabis use and route of administration as well as any alcohol and other drug use.

    Measured: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

  14. Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks

    Working Memory will be assessed using the Wechsler Memory Scale (WMS) and the California Verbal Learning Test (CVLT). The Wisconsin Card Sort Task (WCST) assesses abstraction and the ability to shift or maintain cognitive set. The Hypothetical Monetary Delay Discounting (HMDD) and the Iowa Gambling Task (IGT) measure decision-making. Lastly, the Word Color Stroop (WCS) task assesses selective attention capacity and skills.

    Measured: Administered at a pre-treatment visit (the baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).

  15. Assess physiological measures throughout the study as a safety check

    Physiological measures include blood pressure, heart rate, oxygen saturation, and skin temperature checks at all study visits

    Measured: Administered at every study visit: both pre-treatment visits (the initial screening and baseline visit); during the 12-week treatment phase (all twelve weekly visits); and the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months

  16. Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD.

    Biological measures include collection of urine, saliva, and blood. Saliva will be used to measure biomarkers like cortisol and test for endocannabinoid levels. Urine will be used to measure THC and CBD and their metabolites. Blood plasma will be used to measure plasma concentrations of endocannabinoids, cannabinoids, and PUFA metabolites.

    Measured: Biological samples may be collected at a pre-treatment (at the baseline visit); during the 12-week treatment phase; and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start22 Sep 2025
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06381180
Sponsor's protocol ID
Warrior CARE: CBH
Acronym
CBH
Status last verified
Aug 2026
First submitted
17 Jan 2023
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Tashkin DP, Roth MD. Pulmonary effects of inhaled cannabis smoke. Am J Drug Alcohol Abuse. 2019;45(6):596-609. doi: 10.1080/00952990.2019.1627366. Epub 2019 Jul 12.

    PubMed 31298945

  • Huang YH, Zhang ZF, Tashkin DP, Feng B, Straif K, Hashibe M. An epidemiologic review of marijuana and cancer: an update. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):15-31. doi: 10.1158/1055-9965.EPI-14-1026.

    PubMed 25587109

  • Taylor DR, Fergusson DM, Milne BJ, Horwood LJ, Moffitt TE, Sears MR, Poulton R. A longitudinal study of the effects of tobacco and cannabis exposure on lung function in young adults. Addiction. 2002 Aug;97(8):1055-61. doi: 10.1046/j.1360-0443.2002.00169.x.

    PubMed 12144608

  • Tashkin DP, Simmons MS, Sherrill DL, Coulson AH. Heavy habitual marijuana smoking does not cause an accelerated decline in FEV1 with age. Am J Respir Crit Care Med. 1997 Jan;155(1):141-8. doi: 10.1164/ajrccm.155.1.9001303.

    PubMed 9001303

  • Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.

    PubMed 17606655

  • Baldwin GC, Tashkin DP, Buckley DM, Park AN, Dubinett SM, Roth MD. Marijuana and cocaine impair alveolar macrophage function and cytokine production. Am J Respir Crit Care Med. 1997 Nov;156(5):1606-13. doi: 10.1164/ajrccm.156.5.9704146.

    PubMed 9372683

  • Tetrault JM, Crothers K, Moore BA, Mehra R, Concato J, Fiellin DA. Effects of marijuana smoking on pulmonary function and respiratory complications: a systematic review. Arch Intern Med. 2007 Feb 12;167(3):221-8. doi: 10.1001/archinte.167.3.221.

    PubMed 17296876

  • Tashkin DP, Fligiel S, Wu TC, Gong H Jr, Barbers RG, Coulson AH, Simmons MS, Beals TF. Effects of habitual use of marijuana and/or cocaine on the lung. NIDA Res Monogr. 1990;99:63-87. No abstract available.

    PubMed 2267014

  • Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

    PubMed 1932883

  • Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.

    PubMed 660402

  • Stiglmayr C, Schimke P, Wagner T, Braakmann D, Schweiger U, Sipos V, Fydrich T, Schmahl C, Ebner-Priemer U, Kleindienst N, Bischkopf J, Auckenthaler A, Kienast T. Development and psychometric characteristics of the Dissociation Tension Scale. J Pers Assess. 2010 May;92(3):269-77. doi: 10.1080/00223891003670232.

    PubMed 20408027

  • Briere, J. (2002). Multiscale Dissociation Inventory Professional Manual. Odessa, Florida: Psychological Assessment Resources.

  • Delis DC, Freeland J, Kramer JH, Kaplan E. Integrating clinical assessment with cognitive neuroscience: construct validation of the California Verbal Learning Test. J Consult Clin Psychol. 1988 Feb;56(1):123-30. doi: 10.1037//0022-006x.56.1.123. No abstract available.

    PubMed 3346437

  • Budney AJ, Novy PL, Hughes JR. Marijuana withdrawal among adults seeking treatment for marijuana dependence. Addiction. 1999 Sep;94(9):1311-22. doi: 10.1046/j.1360-0443.1999.94913114.x.

    PubMed 10615717

  • Heishman SJ, Evans RJ, Singleton EG, Levin KH, Copersino ML, Gorelick DA. Reliability and validity of a short form of the Marijuana Craving Questionnaire. Drug Alcohol Depend. 2009 Jun 1;102(1-3):35-40. doi: 10.1016/j.drugalcdep.2008.12.010. Epub 2009 Feb 13.

    PubMed 19217724

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tetrahydrocannabinol and Cannabidiol 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leslie Lundahl, PhD (3139931374, llundahl@wayne.med.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. (time frame: Administered at a pre-treatment visit (at the initial screening visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).). The study lists 5 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 NCT06381180, which also lists 53 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 7 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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