Cannabidiol for Stress
(SCANS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how cannabidiol (CBD), a compound in cannabis, affects the body's stress response. Researchers aim to understand its impact on brain function, hormones, and behavior in individuals who frequently experience stress or anxiety. Participants will receive either an oral CBD solution or a placebo (a non-active substance) to compare effects. Individuals who have experienced significant past stress or trauma and currently feel moderate to high stress might be suitable for this study. As a Phase 1 and Phase 2 trial, the study focuses on understanding how CBD works in people and measuring its effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications before joining the trial. Specifically, you cannot use psychoactive drugs, cannabis products, or medications that affect brain function and stress response for a specified period before and during the study.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that cannabidiol (CBD) is generally safe for use. One study found that participants who took doses up to 25 mg per kilogram of body weight daily experienced some instances of elevated liver enzyme levels, indicating liver stress, though this was uncommon and usually mild.
Another study tested a 600 mg oral dose of CBD and found it effective in managing anxiety. Avoid mixing CBD with alcohol or certain medications, as this can increase the risk of side effects. Overall, CBD is considered a safe option for treating anxiety and stress, with a low risk of serious harm or addiction, especially compared to some other medications.12345Why do researchers think this study treatment might be promising?
Researchers are excited about cannabidiol (CBD) for stress because it offers a novel approach compared to traditional treatments like SSRIs, therapy, or benzodiazepines. Unlike most current medications that work by altering serotonin levels or acting on the central nervous system, CBD interacts with the body's endocannabinoid system, potentially providing relief without the sedative effects or dependency risks associated with some conventional drugs. This makes CBD an intriguing option for those seeking a natural and potentially faster-acting alternative for stress management.
What evidence suggests that cannabidiol might be an effective treatment for stress?
Research shows that cannabidiol (CBD), which participants in this trial may receive, might help reduce stress. One study found that people using CBD experienced a noticeable drop in anxiety symptoms, with some showing a 15% decrease. Another study revealed that many people use CBD primarily to relieve stress, suggesting its effectiveness. Although information on its long-term effects remains limited, current evidence suggests CBD could be a promising option for managing stress and anxiety.45678
Who Is on the Research Team?
Keren Bachi, PhD
Principal Investigator
Ichan School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals with anxiety disorders, nerve injury, trauma, or stress from early life adversity. Participants should be interested in how Cannabidiol (CBD) might help manage stress. Specific inclusion and exclusion criteria are not listed but typically involve age ranges, health status, and other factors relevant to the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oral CBD solution (400 mg) or placebo in a double-blind, randomized, placebo-controlled design
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measurement of cortisol and other stress markers
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol
Trial Overview
The study is testing whether CBD can help regulate stress response compared to a placebo. It involves neuroimaging to observe brain function and will measure changes in neurometabolic activity, hormone levels, and behavior.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Cannabidiol - oral CBD solution 400 mg
Drug: Placebo Inactive oral solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
Therapeutic potential of cannabidiol (CBD) in anxiety ...
In a study evaluating long-term administration of CBD, after 1 month of treatment, CBD patients experienced symptom reductions of approximately 25% and 16% ( ...
Cannabidiol as a Potential Treatment for Anxiety Disorders
Thus, overall, no outcome data are currently available regarding the chronic effects of CBD in the treatment of anxiety symptoms, nor do any data exist ...
Cannabidiol usage, efficacy, and side effects
Among the total sample, the most common reasons for using CBD products were stress (65.3%), sleep problems (51.7%), overall well-being ...
open-label data from a two-stage, phase 2 clinical trial
Patients quickly achieved and maintained ≥15% reduction of anxiety symptoms with most patients demonstrating clinically significant treatment ...
5.
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
Insomnia: Studies suggest that CBD may help with both falling asleep and staying asleep, in part by helping address chronic pain and anxiety.
6.
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 ...
Cannabidiol Adverse Effects and Toxicity - PMC
Six-hundred mg oral CBD was evaluated for its effects on persecutory ideation and anxiety in a high paranoid trait group (n=32) 130 min before entering a ...
Cannabidiol (CBD) – Potential Harms, Side Effects, and ...
Do not use CBD concurrently with medications, alcohol, or illicit drugs. ○ If you experience adverse events as a result of using CBD products, report them to ...
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