CBD for Stress

Overseen By Stress and Resilience Research Labs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: CBD

Disqualifiers: Unstable psychiatric, Uncontrolled hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2.5 hours

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how regular CBD (Cannabidiol) use affects stress responses in adults. Researchers will compare individuals who use CBD regularly with those who do not to assess its impact on the body's reaction to stress. The study will also examine factors like tobacco use. It suits adults who maintain a regular sleep schedule and either use CBD daily or not at all. As an unphased trial, it offers participants the chance to contribute to understanding the broader effects of CBD on stress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

Is there any evidence suggesting that cannabidiol (CBD) is likely to be safe for humans?

Studies have shown that cannabidiol (CBD) is generally safe for use. Common side effects include fatigue, diarrhea, and changes in appetite or weight. Some research has found that CBD can increase liver enzyme levels, indicating potential liver stress, particularly at higher doses exceeding 25 mg per kilogram of body weight daily.

Other possible side effects include nausea, fatigue, and irritability. CBD can also alter the effectiveness of other medications, especially blood thinners. While CBD is often safe for many, it may cause dry mouth and drowsiness. Consulting a doctor is advisable to determine if CBD is appropriate, especially when taking other medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for stress, which often include medications like benzodiazepines or SSRIs, cannabidiol (CBD) offers a unique approach by leveraging its natural origin from the cannabis plant. Researchers are excited about CBD because it interacts with the body's endocannabinoid system, which plays a role in regulating mood and stress responses. Additionally, CBD is non-psychoactive, meaning it doesn't produce the "high" associated with other cannabis compounds, potentially offering a more natural and side-effect-free alternative for managing stress.

What evidence suggests that cannabidiol might be an effective treatment for stress?

Research has shown that cannabidiol (CBD) can help reduce stress and anxiety. In one study, participants using CBD experienced a symptom decrease of up to 25% after a month. Another study found that CBD significantly lowered anxiety, with many users noticing improvements. CBD is often used for stress relief, with 65.3% of users citing stress as their main reason for using it. This trial will include both CBD users and non-users to further explore its potential benefits. These findings suggest that CBD may help calm the mind and ease anxiety. ^{3 6 7 8 9}

Who Is on the Research Team?

Mustafa al'Absi

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults who experience stress. It's designed to see if using cannabidiol (CBD) regularly affects how the body and mind respond to stress. Participants should either be current regular users of CBD or not use it at all. Other factors like tobacco use will also be considered.

Inclusion Criteria

I am between 21 and 70 years old and in good health.

Must keep a normal sleep schedule (sleep during nighttime, awake during daytime)

I either use CBD regularly or not at all.

Exclusion Criteria

Self-reported current pregnancy

Self-reported current use of illicit substances (other than cannabis)

Non-compliance with instructions for study visit (abstinence from alcohol, caffeine, physical activity, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo acute stress testing with measurements of cardiovascular activity and cortisol levels, and self-report subjective states

2.5 hours

Follow-up

Participants are monitored for any delayed effects or additional data collection post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The study is testing the impact of CBD on acute stress response by comparing two groups: those who regularly take CBD and those who don't. Researchers aim to understand how regular CBD use might alter psychological and biological reactions to stress.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

Participants will include CBD users and non users

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124003342

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% ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4604171/

Cannabidiol as a Potential Treatment for Anxiety Disorders We found that existing preclinical evidence strongly supports CBD as a treatment for generalized anxiety disorder, panic disorder, social anxiety disorder, ...

3. health.harvard.edu health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496

Cannabidiol (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.

4. nature.com nature.com/articles/s43856-022-00202-8

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. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1356009/full

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment ...

7. fda.gov fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trial

CDER 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. mayoclinic.org mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/is-cbd-safe-and-effective/faq-20446700

CBD: Safe and effective? CBD use also carries some risks. Though it's often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0278691523002016

Review of the oral toxicity of cannabidiol (CBD) However, toxicity studies indicate that orally consumed CBD can cause significant toxicological effects, including adverse effects on the male reproductive ...