Marijuana Use, Extinction Learning, and Exposure Therapy in Individuals With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
研究概览
简要总结
This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. This study will assess how individuals with PTSD with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to PTSD symptom reduction.
详细描述
In this study, 36 patients with chronic PTSD and heavy marijuana use (heavy) and 36 patients with chronic PTSD and no marijuana use (no use) will be recruited to examine the effects of marijuana use on behavioral (emotional experiencing), physiological (skin conductance, acoustic startle) and biological (cortisol, blood pressure) responding on a well-established discriminative conditioning and extinction paradigm. To examine real world therapeutic implications, we will also examine how individuals with PTSD and heavy or no marijuana use differentially respond to a brief (6 session, 50 min) daily imaginal exposure (IE) treatment. Throughout treatment, we will monitor level of cannabis metabolites in urine samples of marijuana users to correlate effects to outcomes and preliminarily explore how varying levels of cannabis metabolites affect extinction processes. Independent evaluators will assess patients at baseline, 4 weeks, and 12 weeks following study entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current PTSD diagnosis based on DSM-5 criteria, with a minimum duration of 12 weeks since the traumatic event;
- •Between the age of 18 and 65;
- •Current heavy marijuana use (5+ days per week for 3+ months) or no marijuana use in the last 3 months
- •Current diagnosis of a cannabis use disorder based on DSM-5 or no current diagnosis of a substance use disorder
排除标准
- •Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-
- •Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- •Unwilling or unable to discontinue current trauma-focused psychotherapy
- •Any previous experience with prolonged exposure (PE) treatment
- •No clear trauma memory or trauma before age 3
- •Unstable dose of psychotropic medications in the prior 3 months
- •Ongoing intimate relationship with the perpetrator (in assault related PTSD cases).
- •Current diagnosis of a substance use disorder according to DSM-5, other than marijuana in the last 3 months.
研究组 & 干预措施
Heavy marijuana use
Heavy marijuana users with PTSD
干预措施: Brief Imaginal Exposure (Behavioral)
No marijuana use
Non-marijuana users with PTSD
干预措施: Brief Imaginal Exposure (Behavioral)
结局指标
主要结局
Change in Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
时间窗: 12 Weeks
The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline, 4 week, and 12 week follow up to assess change in PTSD symptoms
Treatment drop-out
时间窗: 2 Weeks
Defined as completion of less than 5 of 6 sessions of IE treatment
次要结局
- Change in Quick Inventory of Depressive Symptomatology (QIDS-SR16)(baseline, 4 week, and 12 Weeks)
- Change in Marijuana Problems Scale (MPS)(baseline, 4 week, and 12 Weeks)
- Change in Marijuana Frequency and Quantity(baseline, 4 week, and 12 Weeks)
研究者
Michele Bedard-Gilligan
Assistant Professor
University of Washington