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cbd clinical trials for anxiety

The researchers noted that additional trials will be important to examine the outcomes of CBD among patients with other anxiety-related disorders, such as general anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. They also suggest that future studies should explore the optimal dose and administration route for CBD and assess its safety in the long term.

“Anxiety disorders are highly prevalent worldwide and treatment options tend to have adverse side effects and the majority of patients do not achieve complete remission,” explained Wright, a doctoral student affiliated with the Centre for Addiction and Mental Health and the University of Toronto.

“The main takeaway from this review is that early research indicates that CBD may reduce anxiety in healthy volunteers,” Wright explained. “The results from studies in animals are promising, suggesting that CBD may reduce anxiety, stress, panic and compulsive-like behaviors.”

“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.”

A new report published in the journal Cannabis and Cannabinoid Research presents an overview of the clinical findings concerning the effectiveness of cannabidiol (CBD) in the treatment of anxiety. While the report suggests that CBD may offer a safe and effective treatment for anxiety, the authors highlight the need for additional research among the female population.

Wright and her colleagues reviewed the current findings from both pre-clinical and clinical trials to shed light on the potential role of CBD in the treatment of anxiety.

“The rates of anxiety disorders are nearly doubled in females compared to males, there are differing anxiety-related symptoms and responses to psychotropic medications between the sexes, and CBD has different effects on the body in males and females,” Wright explained. “Therefore, it is important that future research examines sex and gender differences in the utility of CBD as a potential treatment for anxiety disorders.”

Intervention Type: Drug

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.

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)

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

Intervention Type: Drug

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.

Arm Group Label: Cannabidiol (CBD) Oil Capsules

Description: 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)

Chief Investigator: Professor Paul Amminger (Orygen)

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.

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.

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