NOTE: ALL STUDY PROCEDURES ARE COMPLETED AT PARTICIPANTS’ HOMES. NO VISITS TO OUR RESEARCH LABORATORY ARE REQUIRED.
12. Has home access to the internet.
Study Design Overview: The research plan is to conduct a Phase II double-blind placebo controlled randomized clinical trial comparing the efficacy of two CBD oil (300 mg./day) versus Placebo Oil.
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. 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.
Specific aims of the project include:
Nightly dosing of a hemp-derived formulation of purified CBD isolate (300 mg), CBD Broad Spectrum (300 mg.) or matching placebo oil daily for 8 weeks. Individual doses of both CBD formulations and placebo oil will be provided in identical individual plastic syringes. All patients, PI, and staff who interact with study participants will be blind to participants’ assigned treatment condition.
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=150) meeting full DSM-5 criteria for post-traumatic stress disorder (PTSD) will be randomized to one of 3 treatment arms: (a) CBD -Isolate; (b) CBD-Broad Spectrum; (c) Placebo oil.
P ost-traumatic stress disorder (PTSD) is a relatively common psychiatric condition with a lifetime prevalence of 6.1% in the United States. 1 PTSD often presents in clusters of symptoms, including the re-experiencing of traumatic events through intrusive memories and nightmares, avoidance of certain distressing factors, and alterations in mood, level of arousal, and cognition. Psychotherapy is the established first-line treatment for PTSD, and various psychiatric medications are also typically employed. The development of additional treatment agents is important because current medications, including selective serotonin reuptake inhibitors, serotonin/norepinephrine reuptake inhibitors, antiadrenergic agents, and second-generation antipsychotics, have questionable efficacy and often carry significant undesirable side-effect profiles.
2 Department of Psychiatry, University of Colorado Denver, Denver, CO.
Objectives: Cannabidiol (CBD) is a non-psychotomimetic cannabinoid compound that is found in plants of the genus Cannabis. Preclinical research has suggested that CBD may have a beneficial effect in rodent models of post-traumatic stress disorder (PTSD). This effect is believed to be due to the action of CBD on the endocannabinoid system. CBD has seen a recent surge in research regarding its potential value in a number of neuro-psychiatric conditions. This is the first study to date examining the clinical benefit of CBD for patients with PTSD.
Current evidence regarding the use of CBD for PTSD in humans is minimal. One case report showed that administration of 12–37 mg of oral CBD daily was associated with a reduction in anxiety symptoms and sleep disturbances in a 10-year-old patient with PTSD due to sexual trauma. 16 Another study showed that 32 mg of inhaled CBD resulted in consolidation of aversive memory extinction and attenuation of explicit fearful responding in healthy human subjects. 17 See Bittencourt and Takahashi 18 for a recent comprehensive review of pre-clinical and clinical studies regarding the relationship of CBD to PTSD. To date, no clinical trial evaluating the effectiveness of CBD in reducing symptoms of PTSD in humans has been completed.
3 School of Social Work, Colorado State University College of Health and Human Sciences, Fort Collins, CO.