Over 80% of Americans are exposed to a significant trauma sometime during their lifetime1,2 and approximately 7% will meet for a threshold diagnosis of posttraumatic stress disorder.1,3 PTSD is the costly anxiety-related disorder and confers significant interference in work, social functioning, as well as increasing one’s risk for other physical and mental health problems, and a four-fold increase in suicide rates compared to the general population. Over the past two decades, trauma-focused psychotherapies for PTSD have been shown to outperform more traditional supportive psychotherapy or pharmacotherapy and have become the first-line treatment for PTSD.4 Despite these advances, trauma-focused treatments such as prolonged exposure therapy (PE) are associated with high rates of treatment refusal, and among those who do enter treatment, approximately 25% drop out. These data highlight the need to develop PTSD treatment strategies that are both effective and more palatable to patients. More recently, there's been considerable excitement in the press over the potential therapeutic use of cannabidiol (CBD) products in the treatment of a variety of physical and mental health problems. Delta-9-tetrahydrocannabinol (delta-9 THC) is still illegal in most states because of its psychoactive abuse potential. In contrast, cannabidiol (CBD) does not convert to THC in the body and has negligible side effects relative to mainstream psychiatric drugs (benzodiazepines and antidepressants) commonly prescribed for the treatment of PTSD. Mounting evidence from studies with rodents suggests that CBD may confer significant promising health-related benefits including anti-inflammatory, pain-relieving, anti-cancer, memory enhancement, and facilitation of fear extinction (see 5 for a recent review). The biggest success story for CBD use in humans to date comes from controlled randomized clinical trials demonstrating a 50% or more reduction in previously intractable seizures in children suffering from Dravet syndrome6 and Lennox-Gastaut syndrome7 Moreover, several controlled clinical trials have shown promising findings in reducing psychotic symptoms among patients with schizophrenia8 and among young adults displaying THC-induced psychosis. Preliminary Evidence that CBD may offer promise in the treatment of anxiety-related disorders has started to emerge. A small pilot trial with 24 patients presenting with social anxiety disorder found that relative to placebo, a single dose of 100 mg of CBD oil led to lower levels of anxiety, cognitive impairment, and discomfort in their actual speech performance as well as their anxiety before the speech.9 Unfortunately, human treatment studies for anxiety-related problems is limited almost exclusively to single-dose effects on an anxiety challenge task. Studies are clearly needed to assess the effects of multi-dose CBD treatments across the full spectrum of trauma and anxiety-related disorders such as posttraumatic stress disorder. Purpose of the Research: The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of post-traumatic stress disorder using a rigorous double-blind randomized clinical trial methodology. Participants (n=120) meeting full DSM-5 criteria for post-traumatic stress disorder (PTSD) will be randomized to one of two treatment arms: (a) CBD oil vs. (b) Placebo oil. We predict that patients receiving CBD oil will show significantly greater improvements in PTSD symptoms and functional impairment at the posttreatment, one month, and three month follow-up assessments relative to patients receiving placebo oil.
1. Good social skills 2. Familiarity with Qualtrics survey platform (preferred but not required) 3. Conscientious 4. Reliable
We are currently recruiting research subjects. The project will be ongoing for at least the next two years.
Managing patients compliance with the study protocol, conducting weekly web-based assessments of patients' clinical status.
