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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic agent, and is most supported by the scientific community as an antiepileptic. Additionally, CBD is also associated with claims related to improvements in overall health, pain, anxiety, depression, and sleep; however, the scientific evidence is lacking. The overarching goal of this investigation is to determine the effects of a 4-week CBD intervention on measures of overall health, pain, anxiety, depression, and sleep in a population of US veterans. Primary aims will explore the effects of 4 weeks of CBD on pain, anxiety, and depression. Secondary aims will determine whether 4 weeks of CBD will affect general measures of overall health and sleep.

Research Team

Laura Stewart, PhD

Principal Investigator

University of Northern Colorado

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+