Cannabidiol for Veterans' Health and Well-being
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.12345Why 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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 50 mg of CBD or placebo daily for 4 weeks
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 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?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will take capsules containing 50 mg of CBD daily for 4 weeks.
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:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Northern Colorado
Lead Sponsor
Citations
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.
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.
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 ...
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clinicaltrials.gov
clinicaltrials.gov/study/NCT05850754?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(vantage)))&rank=5Study 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 ...
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 ...
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.
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.
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 ...
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