A Phase 1/2 interventional study of Tetrahydrocannabinol and Cannabidiol in Post Traumatic Stress Disorder, Cannabis Use and Suicide, sponsored by Wayne State University. Recruiting at 1 site in United States. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Wayne State University · Phase 1/2, Interventional, and Treatment
This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 500 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC)
Drug: Tetrahydrocannabinol
Cannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD)
Drug: Cannabidiol
Cannabis 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)
Drug: Tetrahydrocannabinol · Drug: Cannabidiol
Cannabis with \<1mg THC and \<1mg CBD; up to a maximum of 5 doses/day (max dose = \<5 mg THC and \<5 mg CBD)
Drug: Placebo
Plant cannabis that will be smoked
Also known as: THC
Plant cannabidiol that will be smoked
Also known as: CBD
Plant will be smoked.
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.
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).
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.
Time frame: 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
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.
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).
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.
Time frame: 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
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).
Time frame: 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
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.
Time frame: Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).
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.
Time frame: Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).
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.
Time frame: 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).
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").
Time frame: Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).
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.
Time frame: Administered once at a pre-treatment visit, specifically at the initial screening visit.
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.
Time frame: Administered once at a pre-treatment visit, specifically at the baseline visit.
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.
Time frame: Administered once at a pre-treatment visit, specifically at the baseline visit.
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: 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
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.
Time frame: 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).
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
Time frame: 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
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.
Time frame: 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)
Plan to share: Yes
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Studies of the drugs tested here: Dronabinol · Cannabidiol
Stress Disorders, Post-Traumatic →