NCT05850754

4 Week Veterans Cannabidiol Intervention

American Veterans 4 Week Cannabidiol Intervention

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Northern Colorado · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

In this double-blind investigation, participants will undergo 6 online assessments. Two assessments (assessments 1 and 2) will take place before the intervention period and assessments 3-6 will be conducted at the end of every week during the intervention period (assessment 3 at the end of week one, assessment 4 at the end of week 2, assessment 5 at the end of week 3 and assessment 6 at the end of week 4). After participants (N=100) reach out to inquire about the study, they will be provided with an informed consent, and they will be asked to obtain physician approval to participate in the study. Once this approval is obtained, they will be randomized into either a cannabidiol ingesting group (CG, n=50, 50 mg of CBD per day)) or a placebo-controlled group (PC, n=50, 0 mg of CBD per day). Then, they will be sent a link to a survey which includes questions evaluating overall health, anxiety, depression, pain and sleep. The details of these surveys are outlined below. Once researchers receive a completed assessment 1, the participants will be mailed packages containing bottles of either CBD or a placebo capsules (32 capsules provided in each bottle). One week after assessment 1, participants will complete assessment 2 and will begin to take one capsule per day in the evening after their last meal. Participants will take the same online surveys in all assessments with the exception of the initial informed consent (in visit one only) as well as a few open-ended study experience questions in assessment 6. During the intervention period, all participants will complete capsule logs in which they confirm that they have consumed one of their assigned capsules each day. Subjects will take a picture and email the log back to researchers at the end of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vantage Hemp CBD	Participants will consume 1 Vantage Hemp capsule, daily for 4 weeks.
DIETARY_SUPPLEMENT	Vantage Hemp Placebo Capsule	Vantage Hemp Placebo Capsule Intervention

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-05-09
• Last updated: 2024-06-03

Locations

1 site across 1 country: United States