Wayne Warrior CAnnabis Research and Education: Naturalistic Observation and Harm Reduction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
结局指标
主要结局
Change in Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: 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 Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5)
时间窗: 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)
时间窗: 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 Suicide Behavior Questionnaire - Revised (SBQ-R)
时间窗: 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.
次要结局
- Exploratory analysis of genetic markers associated with endocannabinoid system(Baseline)
- Change in Beck Depression Inventory-II(Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline)
- Change in California Verbal Learning Test(Baseline, 3, 6, 12 months post baseline)
- Change in Quality of Life Inventory(Baseline, 3, 6, 12 months post baseline)
- Change in Brief Pain Inventory(Baseline, 3, 6, 12 months post baseline)
- Change in Iowa Gambling Task(Baseline, 3, 6, 12 months post baseline)
- Change in State Trait Anxiety Inventory Form Y(Baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline)
- Change in General Health Survey (Short form 36)(Baseline, 3, 6, 12 months post baseline)
- Change in Wisconsin Card Sort Task(Baseline, 3, 6, 12 months post baseline)
研究者
Leslie Lundahl
Associate Professor
Wayne State University