Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Treatment Response
研究概览
简要总结
The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and/or suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.
详细描述
The total time commitment estimated per participant is 20 study visits. This is approximated below:
Visit 1: Screening Consent and Screening Assessments: During this visit the potential participant will learn about the study procedures and sign the screening informed consent documents, then complete screening measures which will include a clinical interview (i.e., assessments of PTSD and other psychiatric diagnoses, suicidality, medical history, etc.), a physical examination, and various questionnaires. At this time, they will collect blood, urine, breathalyzer and saliva samples.
Visit 2: Study consent and Baseline Assessments: During this visit the participant will be asked to read the study informed consent form and will have an opportunity to have any questions answered before agreeing to participate in the study. Particular attention will be given to reviewing required procedures and possible side effects of the drugs (THC and CBD) with participants.
Visit 3: Pre-Treatment Behavioral Tests and Magnetic Resonance (MR) Scan: During this visit the participant will complete several computer tasks, and the study staff will be measuring reaction time and psychophysiological measures. The tasks that the participant will perform will show three different images and an aversive stimulus (e.g. which will be a mild electric shock to the ankle paired with a snake hissing sound of an animated snake) may follow one image most of the time, while the other images may never be followed by the aversive cue. The participant will need to try to predict whether the aversive cue will occur or not based on which image is shown and will be asked to repeatedly rate on a scale how likely it is that he or she thinks an aversive cue will occur after each image. Lastly, during the session the participant will also be asked to report his or her level of anxiety on a scale from 0 to 100.
Visit 4: Pre-Treatment Behavioral Tests with MR Scan: This visit will be very similar to Visit 4. Participants will participate in the same type of task inside the MR scanner, while the study staff measures reaction time and psychophysiological responding and brain activation. Participants will view the same images he or she did previously and may experience the same aversive stimulus as during Visit 3. Participants will again be asked to rate how much they expect to experience the aversive stimulus after each image and will also be asked to report their level of anxiety on a scale from 0 to 100.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to consent to the study
- •Agree to comply with requirements and procedures
- •Veteran who has served in a branch of the US armed forces
- •Between ages 18-60
- •Report using cannabis within the past three years but not more than twice in the past month
- •Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5); trauma does not have to be related to combat or military service
- •Significant PTSD severity as indicated by CAPS-5 diagnosis and/or score >= 25 of at least one month prior to study entry, PTSD is patient's primary concern
- •not currently receiving any psychotherapy for PTSD
排除标准
- •Pregnant, lactating or are a heterosexually active, pre-menopausal woman who is NOT using medically approved birth control (e.g., oral or depot contraception, contraceptive implant, IUD, condom/foam, sterilization, tubal ligation)
- •Current or past diagnosis of any bipolar or related disorder or schizophrenia spectrum and other psychotic disorder as determined by the SCID-5 or previous diagnosis by a licensed psychologist or psychiatrist
- •Determined to be at high risk for suicide requiring immediate intervention based on the C-SSRS and/or clinician judgment
- •Meet criteria for substance use disorder other than Cannabis Use Disorder or Alcohol (Mild or Moderate) or Nicotine Use Disorder, determined by the SCID-5
- •Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to smoking cannabis
- •Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with cannabis
- •Currently receiving psychotherapy for PTSD or previously received exposure-based PTSD treatment
- •Current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, systemic, pulmonary, pulmonary fibrosis, or other forms of restrictive lung disease, immunocompromising, or neurological disease
- •Current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD
- •Cognitive exhibit impairment
- •Lack of fluency in English
- •Insufficient memory of the index traumatic event
- •Pervasive development disorder history
- •Seeking or currently undergoing treatment for Cannabis Use Disorder.
- •Traumatic brain injury (TBI) with current cognitive impairment related to TBI
- •Exclusively left-handed (score of -100 on Handedness Questionnaire)
- •claustrophobic
- •MRI contraindications (e.g., ferrous metal in head/body)
研究组 & 干预措施
Placebo (PBO) only
In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
干预措施: Placebo only (Drug)
Cannabidiol (CBD) only
In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
干预措施: Cannabidiol (CBD) only (Drug)
Delta-9-tetrahydrocannabinol (THC) only
In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
干预措施: Delta-9-tetrahydrocannabinol (THC) only (Drug)
THC:CBD 1:1
In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC/CBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.
干预措施: THC:CBD 1:1 (Drug)
结局指标
主要结局
Treatment Response
时间窗: Through study completion, an average of 12 months
Clinician Administered PTSD Scale for DSM-5 (CAPS-5 Score), anxiety, mood, suicidality, disability. The CAPS-5 is a clinician interview that determines the presence and severity of PTSD consistent with the Diagnostic \& Statistical Manual 5 (DSM-5) and allows for assessing changes in symptom severity over time. PTSD diagnosis is based on meeting the DSM-5 symptom cluster criteria (minimum threshold of symptoms with a score ≥ 2) with a qualifying criterion A index trauma. The CAPS-5 Total Severity Score is calculated by summing the total score for each of the four symptom categories to assess past-month PTSD symptoms on a specific traumatic event: intrusion (Category B), Avoidance (Category C), Mood and Cognition (Category D), and Hyperarousal (Category E). CAPS-5 Total Severity scores range from 0-80, where higher scores indicate worse PTSD severity.
次要结局
- Urine Drug Toxicology tests(through study completion, an average of 12 months)
- Cannabinoid concentration - Saliva(through study completion, an average of 12 months)
- TLFB(Administered at every study visit, besides fMRI scanning visits.)
- Heart rate(Throughout the 12-month study)
- Skin temperature(Throughout the 12-month study)
- Oxygen saturation(Throughout the 12-month study)
- Brain measures(Pre and post treatment-Through study completion, an average of 12 months)
- Blood pressure(through study completion, an average of 12 months)
- Heart rate(through study completion, an average of 12 months)
- Skin conductance response(through study completion, an average of 12 months)
- Drug Effects Questionnaire (DEQ)(through study completion, an average of 12 months)
- Visual Analogue Scale of Mood (VAS)(through study completion, an average of 12 months)
- Quality of Life Inventory (QOLI)(through study completion, an average of 12 months)
- Pittsburgh Sleep Quality Index (PSQI)(through study completion, an average of 12 months)
- Epworth Sleepiness Scale (ESS)(through study completion, an average of 12 months)
- Brief Pain Inventory (BPI)(through study completion, an average of 12 months)
- Short form 36(through study completion, an average of 12 months)
- fMRI(through study completion, an average of 12 months)
- Psychophysiology(through study completion, an average of 12 months)
- DNA analysis(through study completion, an average of 12 months)
- Cannabinoid concentration - Blood(through study completion, an average of 12 months)
- Drug/Pregnancy tests(through study completion, an average of 12 months)
- Cannabinoid concentration - Salvia(through study completion, an average of 12 months)
研究者
Leslie Lundahl
Professor
Wayne State University