Cannabidiol for Anxiety

(CALM Trial)

This trial aims to determine if cannabidiol, a compound from the cannabis plant, can enhance the effects of cognitive behavioral therapy (CBT) for adults with generalized anxiety disorder (GAD). It compares different doses of cannabidiol combined with CBT to assess whether they improve anxiety symptoms more effectively than CBT with a placebo. Suitable participants are right-handed adults diagnosed with GAD who do not have severe medical conditions or a history of significant drug use. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.

You may need to stop taking certain medications if they interact with cannabidiol or affect the study. Specifically, you cannot use medications with severe interactions with cannabidiol or those affecting certain liver enzymes. If you're on anti-anxiety meds or other psychoactive drugs, your dose must be stable for at least 4 weeks.

Research shows that cannabidiol (CBD), particularly in the form of EPIDIOLEX®, is generally safe for most people. Most patients use it without serious issues. However, some side effects occur, such as sleepiness in about 25% of people and fatigue in over 5%. There is also a small risk of changes in liver enzymes, especially at higher doses.

Most treatments for anxiety, such as SSRIs or benzodiazepines, work by altering neurotransmitter levels in the brain. However, cannabidiol (CBD) is unique because it interacts with the body's endocannabinoid system, potentially offering a new mechanism to alleviate anxiety symptoms. Researchers are excited about CBD because it is derived from EPIDIOLEX®, a cannabis-based medication, which may offer a more natural alternative to traditional pharmaceuticals. Another distinctive feature is its administration alongside cognitive behavioral therapy (CBT), which could enhance the overall effectiveness of the treatment, especially with its varying doses allowing flexibility to match patient needs.

Research shows that cannabidiol (CBD) can help reduce anxiety symptoms. Studies have found that CBD may greatly improve anxiety, depression, and social interactions. In this trial, participants will receive either a low or moderate dose of CBD combined with brief cognitive behavioral therapy (CBT), or a placebo with CBT. For people with anxiety disorders, CBD has lowered scores on anxiety rating scales like GAD-7 and HAM-A, which measure anxiety severity. Additionally, CBD usually causes fewer side effects than a placebo, making it a promising option for those seeking relief from anxiety symptoms.³⁶⁷⁸⁹