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cbd clinical trials for anxiety

The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of flexibly dosed CBD Oil capsules versus placebo for the treatment of adults, aged 21 to 65 years with a primary Diagnostic and Statistical Manual 5 (DSM-5) anxiety disorder: Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), or agoraphobia. A total 50 participants (n=25/cell) who meet the inclusion criteria will be randomized to receive 1 of 2 treatments in a 1:1 ratio: CBD Oil Capsules or matching placebo, with the possibility of dose titration during this 8-week period. The outcomes of this research will make a significant contribution to enhance our current understanding of the effects of cannabis in anxiety disorders. To be involved in this study, the study doctor will first check that the participant is qualified. This is called screening, and will involve a clinical assessment, physical exam and urine tests. This visit may take up to 3 hours to complete. If the participant successfully completes screening the participant will start treatment in one of the two assigned treatment groups. Treatment is 8 weeks. Participants will come to the study clinic 6 times during the treatment phase of the study. Each visit will last 1 to 2 hours. Each visit will involve reporting any side effects that the participant may have experienced, completing questionnaires about mood and anxiety symptoms, sleep, overall functioning and alcohol and drug use. Participants will also be assessed by the study doctor. The first and last visits will also involve blood work and completing a number of tasks on the computer, which measure focus, attention and memory. Each participant will be involved in the study for a maximum of 10 weeks. This includes the screening visit and follow-up visit.

Arm Group Label: Cannabidiol (CBD) Oil Capsules

Cannabidiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study

Description: 200 mg CBD- titrated as tolerated up to a maximum 2 capsules twice daily (200 mg- 800 mg total dose) Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)

This proposed study aims to evaluate the efficacy of daily Cannabidiol (CBD) Oil Capsules in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and CBD using biological markers as well as examine the neuro-cognitive effects of CBD treatment.

Intervention Type: Drug

“Following the recent push to legalize cannabis in many jurisdictions, CBD has gained a lot of attention from the public and scientific community for its potential therapeutic properties. Given the data demonstrating that CBD is well tolerated and demonstrates little potential for abuse or dependence in humans, we were interested in reviewing the animal and human literature on its use as a treatment option for anxiety disorders.”

“There are still many questions that need to be addressed and rigorously studied,” Wright said. “The only human studies examining CBD as a treatment for anxiety have been conducted in patients with social anxiety disorder, therefore, research is needed in patients with other anxiety disorders, such as generalized-anxiety disorder and panic disorder. Secondly, much remains unknown about the use of CBD as a treatment for anxiety, such as the most effective route of administration, appropriate doses to be used, and its long-term safety and efficacy.”

Next, clinical studies among patients with social anxiety disorder have found anxiety-reducing effects with single doses of either 400 or 600 mg of CBD. During a public speaking simulation task, these doses were found to lower anxiety symptoms, reduce cognitive impairment, and reduce discomfort associated with one’s speech performance. A collection of brain imaging studies additionally revealed that CBD intake alters blood flow in the amygdala, hippocampus, hypothalamus, and cingulate cortex — four brain structures implicated in anxiety.

A growing research trend has focused on the anti-anxiety properties of cannabidiol (CBD) — a compound found in the Cannabis plant. Unlike tetrahydrocannabinol (THC), CBD does not produce a “high”, and studies have yet to uncover any evidence of abuse or dependence in humans.

First, findings from pre-clinical animal studies show that low to medium doses of CBD produce anxiety-reducing effects, while high doses increase anxiety. Animal research also offers evidence that the anxiety-relieving effects of CBD involve the serotonin receptor 5-HT1A. While on the whole, this research shows compelling support for CBD as an anxiety treatment, the researchers note that these studies have only been conducted among male animals.

Chief Investigator: Professor Paul Amminger (Orygen)

This study is a single-centre, 12-week open-label trial of CBD for anxiety disorders. Participants are young people aged 12 – 25 years with a DSM-5 diagnosis of an anxiety disorder who do not respond to evidence-based standard treatment (e.g. CBT or CBT plus SSRIs/SSNRIs). CBD is administered on a fixed–flexible schedule adjusted up to a maximum dose. Each participant will be offered biweekly CBT for 12 weeks (5 sessions). The trial is being conducted at the Headspace Glenroy facility according to Good Clinical Practice guidelines, overseen by the trial sponsor, Orygen – The National Centre of Excellence in Youth Mental Health study service unit.

This is a collaboration between the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney; and Orygen, The National Centre of Excellence in Youth Mental Health.

Project Coordinators: Dr Maximus Berger (Orygen) & Emily Li (Orygen)