Warrior CARE: Cannabis Behavioral Health

Post Traumatic Stress Disorder Clinical Trial

— CBH  

Official title:

Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381180
• Other study ID #: Warrior CARE: CBH
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Wayne State University
• Contact: Leslie Lundahl, PhD
• Phone: 3139933960
• Email: llundahl[@]wayne.med.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 vaporize 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

Inclusion Criteria:

• able to provide informed consent, IQ Score >80,
• served in branch of the US armed forces, report using cannabis,
• report using cannabis (no more than 2x in last month and no more than 100 lifetime use episodes)
• meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration

Exclusion Criteria:

• urine drug screen positive for any other drugs
• systolic/diastolic BP >140/90 mmHg?
• 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 and Alcohol Use Disorder (mild or moderate)
• pregnancy, lactating
• unable to provide informed consent

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana
• Marijuana Abuse
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Suicide
• Veterans

Intervention

Drug:
• Tetrahydrocannabinol
Plant cannabis that will be vaporized
• Cannabidiol
Plant cannabidiol that will be vaporized
• Placebo
Plant will be vaporized.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Primary	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.	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
Primary	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.	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).
Primary	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.	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
Primary	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).	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	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.	Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).
Secondary	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.	Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).
Secondary	Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires.	The Adverse Childhood Experience Questionnaire for Adults (ACE), the Posttraumatic Cognitions Inventory (PCTI), and the Childhood Trauma Questionnaire (CTQ) are all three separate questionnaires used to measure lifetime and childhood trauma.	Administered once at a pre-treatment visit, specifically at the baseline visit.
Secondary	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.	Administered at a pre-treatment visit (at the baseline visit); and at the first post-treatment visit (one week post-treatment).
Secondary	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").	Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).
Secondary	Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires.	The Cross Ethnic-Racial Identity Scale-Adult (CERIS-A) and the Trauma Symptoms of Discrimination Scale (TSDS) are self-report questionnaires we will use to assess ethnic-racial identity attitudes and the traumatizing impact of discrimination.	Administered at a pre-treatment visit (at the baseline visit); and the first post-treatment visit (one week post-treatment).
Secondary	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.	Administered once at a pre-treatment visit, specifically at the initial screening visit.
Secondary	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.	Administered once at a pre-treatment visit, specifically at the baseline visit.
Secondary	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.	Administered once at a pre-treatment visit, specifically at the baseline visit.
Secondary	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.	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).
Secondary	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.	Administered at both pre-treatment visits (the initial screening and baseline visit); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months post-treatment visits).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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	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.	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).
Secondary	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	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	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, and saliva. 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.	Biological samples will be collected at a pre-treatment (at the baseline visit); during the 12-week treatment phase (every two weeks during the treatment phase); and at the four post-treatment visits (one week post-treatment and 3-, 6-, and 9-months po