Title of Project Cannabadiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study
Objective To provide systematic, prospectively derived data on the effects of CBD and THC in anxiety disorders.
Eligibility Criteria Participants must have a primary diagnosis of an anxiety disorder. Eligible participants are between 21-65 years of age, as there is a growing body of scientific evidence that smoked cannabis may have deleterious effects on the developing brain. Patients cannot have a lifetime history of cannabis use disorder or daily cannabis use.
Potential Risks In studies investigating CBD safety, no significant side effects on the central nervous system, or side effects related to heart rate, breathing or temperature or on mood, have been seen at doses of up to 1,500 mg/day. The maximum dose of CBD in this study will be 800 mg/day. In a study involving THC:CBD capsule and oil formulations ranging in dose from 2.5mg:2.5mg to 10mg:10mg, these treatments were found to be generally safe with no serious side effects being reported. Other mild side effects such as euphoric mood, somnolence, dizziness, dry mouth, and ocular hyperaemia were observed in some participants. As there is evidence that THC is addictive, we have included a Marijuana Withdrawal Questionnaire as part of the study, so that we can examine this issue more closely.
End date February 28, 2023
Study Involvement The study takes approximately 11 weeks overall with 7-8 study visits during this time.
Contact Email our Research Assistant at [email protected] , call us at 905-921-7644 or check out our website at http://www.macanxiety.com/current-research/ for more information.

Background:

Many Canadians report using cannabis for anxiety conditions and clinicians are often asked to prescribe it to treat anxiety. Interestingly, there have been no studies evaluating the effects of cannabis or cannabadiol (CBD – the component thought to be most anxiety-relieving) in clinical populations. The legalization of recreational cannabis in Canada has significantly increased the number of Canadians having access to and using cannabis, making the need for evidence-based clinical information critical. This pilot study aims to evaluate the efficacy and safety of cannabis oil capsules in males and females aged 21-65, who have an anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder or agoraphobia). It is a 3-arm 11-week randomized, placebo-controlled study. One arm will be treated with high-dose CBD oil capsules; another will be treated with capsules containing low doses of both CBD and THC, while the last arm will be treated with a placebo. To ensure participants are feeling comfortable with the medication and have time to acclimate to the study drug, our study starts by giving patients a low dose of their medication and week by week increasing the dosage until reaching the maximal dose halfway through the study. After this maximal dose, participants are slowly taken off of the medication each week until getting back to the minimum dose by study week 11. This study will also examine the relationship between inflammation, anxiety and cannabis by using biological markers (cytokines) in the blood and investigating cognitive changes with cannabis treatment. Our study aims to evaluate the short-term efficacy of a High CBD and a Low CBD (THC:CBD) cannabis oil capsule versus placebo in adults with anxiety disorders. We also aim to evaluate the effects of cannabanoids on systemic inflammation, given the known immunomodulatory effects of cannabis and the developing involvement of inflammation in anxiety disorders. Finally, we aim to examine the potential impact of each cannabis oil capsule formulation on neurocognitive functioning. The outcomes of this research will make significant impact on current clinical questions related to our understanding of the effects of cannabis in anxiety disorders as a short term treatment.