Cannabidiol for Veterans' Health and Well-being

Overseen By Edwin Rodriguez, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Northern Colorado

Must not be taking: Anti-seizure, Antidepressants, Blood thinners, others

Disqualifiers: Pregnancy, Mental health, Chronic disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of CBD, a non-psychoactive compound from hemp, on pain, anxiety, depression, sleep, and overall health in U.S. veterans. Participants will take either a CBD capsule or a placebo daily for four weeks to assess its impact on these health aspects. The trial explores whether CBD can improve these conditions, as scientific evidence remains limited. Eligible participants are U.S. veterans with secure internet access who haven't used CBD or cannabis in the last three months. As an unphased trial, this study offers veterans the opportunity to contribute to groundbreaking research on CBD's potential benefits.

Will I have to stop taking my current medications?

Yes, if you are regularly taking certain medications like anti-seizure drugs, blood thinners, antidepressants, anti-inflammatory drugs, muscle relaxants, sedatives, beta and calcium channel blockers, chemotherapy drugs, or HIV antivirals, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that taking CBD orally in small amounts for a short time is usually safe. Some studies have safely administered up to 200 milligrams daily. This trial uses a smaller dose of 50 milligrams daily, well within the safe range.

However, it's important to know that CBD products not approved by the FDA might contain impurities or THC, the component of cannabis that causes a high. While no serious safety issues have been found with CBD itself, caution and informed decision-making are advised. Overall, CBD appears well-tolerated, especially at the doses used in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for veterans' health, which often include medications like antidepressants or antianxiety drugs, cannabidiol (CBD) offers a novel approach. CBD is a compound derived from cannabis plants but doesn't produce the "high" associated with marijuana. Researchers are excited because CBD targets the body's endocannabinoid system, which plays a role in regulating mood and stress, potentially offering a natural and less addictive alternative to traditional pharmaceuticals. Additionally, CBD is administered as a simple daily capsule, which could make it an easy and appealing option for many veterans.

What evidence suggests that this treatment might be an effective treatment for veterans' health and well-being?

This trial will compare the effects of CBD capsules with placebo capsules on veterans' health and well-being. Research has shown that cannabidiol (CBD) may help treat chronic pain, particularly in veterans. Studies have explored its potential to ease pain and improve health. While CBD is well-known for aiding epilepsy, interest in its benefits for anxiety, depression, and sleep problems is growing. Although extensive scientific data on these uses is lacking, some studies suggest that CBD might reduce anxiety and improve sleep. More research is needed to confirm its effectiveness in these areas, but early results are promising. ^{1 3 6 7 8}

Who Is on the Research Team?

Laura Stewart, PhD

Principal Investigator

University of Northern Colorado

Are You a Good Fit for This Trial?

This trial is for US veterans over 18 with internet access who can consent to participate. It's not for pregnant individuals, those planning pregnancy, using illegal drugs, living in states with CBD restrictions, traveling outside the US during the study, allergic to capsule ingredients or having uncontrolled chronic diseases and certain medication use.

Inclusion Criteria

Secure Internet Access: Ability to use an online platform and agreement to take surveys and communicate with the research team while on a private (not public) device and using a private (not public) connection.

Informed Consent: The capability and willingness to give online informed consent, to understand the exclusion criteria, and to accept that the randomized group assignment is required.

Biological Sex: Males or Females, Gender Binary or Non-Binary

Exclusion Criteria

Pregnancy or Planned Pregnancy: Individuals who are pregnant or who are planning to become pregnant.

You are currently using illegal drugs.

Allergy to Capsule Ingredients: Individuals with a known allergy to porcine gelatin, glycerin, medium chain triglycerides (coconut derived), or CBD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (virtual)

Treatment

Participants receive either 50 mg of CBD or placebo daily for 4 weeks

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The trial tests if a 4-week course of Vantage Hemp CBD improves overall health, pain relief, anxiety reduction, depression alleviation and sleep quality in veterans compared to a placebo. Participants will be randomly assigned to receive either CBD or placebo capsules.

How Is the Trial Designed?

Group I: CBD Capsule Experimental Treatment 1 Intervention

Participants will take capsules containing 50 mg of CBD daily for 4 weeks.

Group II: Placebo Capsule Placebo Group 1 Intervention

Participants will take placebo capsules containing 0 mg of CBD daily for 4 weeks.

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of Northern Colorado

Lead Sponsor

Trials

8

Recruited

550+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218053/

Protocol for a pragmatic trial of Cannabidiol (CBD) to improve ... We designed a clinical trial to investigate CBD's effectiveness in managing chronic pain symptoms among Veterans.

2. aidhi.umich.edu aidhi.umich.edu/funded-research2/blog-post-title-two-r9e9y

State of Michigan awards U-M researchers $7.4 million to ... State of Michigan awards U-M researchers $7.4 million to study effect of CBD and medical cannabis therapy on Veterans' chronic pain.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38951902/

Protocol for a pragmatic trial of Cannabidiol (CBD) to improve ... Because Veterans have a high need for improved pain care, we designed a clinical trial to investigate CBD's effectiveness in managing chronic ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05850754?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(vantage)))&rank=5

Study Details | 4 Week Veterans Cannabidiol Intervention An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. research.va.gov research.va.gov/currents/0219-San-Diego-VA-study-testing-cannabidiol.cfm

San Diego VA study testing cannabidiol—a compound ... Researchers at the VA San Diego Healthcare System aim to see whether cannabidiol, or CBD—a compound derived from cannabis plants—can help ease ...

6. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Non-FDA-approved CBD products lack safety standards, may have contaminants, and may contain THC. Limited evidence supports their safety.

7. tandfonline.com tandfonline.com/doi/abs/10.1080/10550887.2024.2355365

Cannabidiol (CBD) and hemp oil use in veterans ... Cannabidiol (CBD) and hemp oil use in veterans using a VA Pain Clinic: a cross-sectional survey study · Abstract · Disclosure statement.

8. webmd.com webmd.com/cannabinoids/cbd-safety-tips-side-effects

Cannabidiol (CBD): Safety and Side Effects Research suggests that CBD is safe when taken orally in small doses for a short period of time. Studies have shown that taking up to 200 milligrams daily for ...