Cannabidiol for Anxiety
(CALM Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Do I need to stop taking my current medications to join the trial?
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
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.
EPIDIOLEX® has FDA approval for other conditions, which can reassure regarding its safety. While more research is always beneficial, many studies suggest that CBD is a relatively safe option for managing conditions like anxiety.12345Why are researchers excited about this trial's treatments?
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.
What evidence suggests that this trial's treatments could be effective for anxiety?
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
Who Is on the Research Team?
Hilary Marusak, PhD
Principal Investigator
Wayne State University
Christine Rabinak, PhD, MBA
Principal Investigator
Wayne State Universty
Leslie Lundahl, PhD
Principal Investigator
Wayne State University
Are You a Good Fit for This Trial?
Adults with generalized anxiety disorder (GAD) who are interested in combining cognitive behavioral therapy (CBT) with FDA-approved cannabidiol (EPIDIOLEX®). Participants must meet specific criteria to join, which will be detailed by the study organizers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with either cannabidiol (EPIDIOLEX®) or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol
Trial Overview
The trial is testing if adding low or moderate doses of cannabidiol to CBT helps better manage GAD compared to a placebo. It's randomized and double-blind, meaning participants won't know if they're getting the real treatment or a dummy pill.
How Is the Trial Designed?
Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with oral cannabidiol (EPIDIOLEX®) at a moderate dose. Dosing starts at 5 milligram/kilogram/day and titrates to 10 milligram/kilogram/day (divided twice a day) after 6 days. Cannabidiol is administered chronically throughout CBT to examine target engagement and symptom outcomes.
Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a lower dose of oral cannabidiol (EPIDIOLEX®), maintained at 5 milligram/kilogram/day (divided twice a day) throughout the treatment period. No titration is required.
Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a matched placebo oral solution. The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the moderate dose cannabidiol arm, dosing starts at 5 milligram/kilogram/day and titrates to 10 milligram/kilogram/day (divided twice a day) after 6 days.
Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a matched placebo oral solution. The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the low-dose cannabidiol arm, dosing is maintained at 5 milligram/kilogram/day (divided twice a day) throughout the treatment period. No titration is required.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wayne State University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
The Impact of Cannabidiol Treatment on Anxiety Disorders
Despite these conflicting outcomes, the data suggest that CBD may reduce anxiety with minimal adverse effects when compared to a placebo. ...
Therapeutic potential of cannabidiol (CBD) in anxiety ...
While CBD has shown significant efficacy in relieving anxiety symptoms overall, its efficacy appears to vary depending on the specific disease subtype being ...
The Effectiveness and Adverse Events of Cannabidiol and ...
Conclusions: Formulations of cannabis significantly improved anxiety, depression, fatigue, and the ability to participate in social activities ...
A double blind multicenter randomized clinical trial
Nanodispersible CBD oral solution was effective treating mild to moderate anxiety. · Nanodispersible CBD reduced GAD-7 and HAM-A scores (primary outcome).
open-label data from a two-stage, phase 2 clinical trial
Conclusions. Results provide preliminary evidence supporting efficacy and tolerability of a full-spectrum, high-CBD product for anxiety.
Cannabidiol Adverse Effects and Toxicity - PMC
Of the 162 patients in the safety and tolerability analysis, 79% reported AEs, 25% somnolence, 11% convulsions, and more than 5% reported somnolence, fatigue, ...
7.
fda.gov
fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trialCDER Investigators Address the Safety of CBD in a ...
At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation was observed., Liver enzyme elevations typically occurred after ...
8.
health.harvard.edu
health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496Cannabidiol (CBD): What we know and what we don't
We need more research, but CBD is proving to be a helpful, relatively nontoxic option for managing anxiety, insomnia, and chronic pain.
Investigating the Effects of Cannabidiol on Social Anxiety ...
The purpose of this study is to test whether a single-dose of Epidiolex (cannabidiol) is associated with reduced psychological, physiological, ...
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