Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Assessing Suicidality over time using the C-SSRS assessment.
研究概览
简要总结
This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Placebo Group
Cannabis with <1mg THC and <1mg CBD; up to a maximum of 5 doses/day (max dose = <5 mg THC and <5 mg CBD)
干预措施: Placebo (Drug)
CBD Group
Cannabis with 5 mg CBD; up to a maximum of 5 doses/day (max dose = 25 mg CBD)
干预措施: Cannabidiol (Drug)
THC & CBD Group
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)
干预措施: Tetrahydrocannabinol (Drug)
THC Group
Cannabis with 5 mg THC; up to a maximum of 5 doses/day (max dose = 25 mg THC)
干预措施: Tetrahydrocannabinol (Drug)
THC & CBD Group
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)
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Assessing Suicidality over time using the C-SSRS assessment.
时间窗: 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 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.
Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment
时间窗: 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
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.
Assessing Suicidality throughout the study using the SBQ-R assessment.
时间窗: 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
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.
Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires.
时间窗: 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
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).
Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment.
时间窗: 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).
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.
次要结局
- Assess emotional state pre- and post-treatment using the PANAS questionnaire.(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.(Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).)
- Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks(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(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 drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales.(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(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.(Administered once at a pre-treatment visit, specifically at the baseline visit.)
- Assess smoking habits and history using the FTND assessment(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.(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 pain pre- and post-treatment using the BPI assessment.(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.(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.(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.(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.(Administered at a pre-treatment visit (at the baseline 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.(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 smoking habits and history using the FTND assessment(Administered once at a pre-treatment visit, specifically at the baseline visit.)
- Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment.(Administered at a pre-treatment visit (at the initial screening visit); and at the first post-treatment visit (one week post-treatment).)
- Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales.(Administered after cannabis administration; therefore, administered at the baseline visit and electronically during the 12-week treatment phase (at all twelve weekly visits).)
- Assess overall quality of life pre- and post-treatment using the QOL questionnaire.(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 biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD.(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))
- Assess demographics using a self-report assessment(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.(Administered once at a pre-treatment visit, specifically at the baseline visit.)
- Assess sleepiness pre- and post-treatment using the ESS questionnaire.(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 general health and history pre- and post-treatment using the SF-36 assessment.(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 pain pre- and post-treatment using the BPI assessment.(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.(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 healthcare utilization throughout the study.(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 neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks(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(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)
研究者
Leslie Lundahl
Professor
Wayne State University