4 Week Veterans Cannabidiol Intervention

May 31, 2024 updated by: Laura Stewart, University of Northern Colorado

American Veterans 4 Week Cannabidiol Intervention

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Greeley, Colorado, United States, 80639
        • University of Northern Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 18 years and older
  • Biological Sex: Males or Females, Gender Binary or Non-Binary
  • Veteran: US Veterans currently residing in the continental United States
  • 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.
  • 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.

Exclusion Criteria:

  • Pregnancy or Planned Pregnancy: Individuals who are pregnant or who are planning to become pregnant.
  • Allergy to Capsule Ingredients: Individuals with a known allergy to porcine gelatin, glycerin, medium chain triglycerides (coconut derived), or CBD.
  • Significant Mental Health Challenges: Presence of moderate to severe mental health challenges including paranoia, manic depression, bipolar disorder, severe depression or who are at risk for suicide.
  • Significant Health Challenges: Presence of an uncontrolled chronic disease (heart disease, cancer, type 2 diabetes, etc) and/or individuals who are regularly taking anti-seizure drugs, blood thinners, antidepressants, anti-inflammatory drugs, muscle relaxants, sedatives, beta and calcium channel blocker and chemotherapy drugs, HIV antivirals. Individuals with seizure disorders.
  • Illegal Substance Use: Individuals who are currently using illegal drugs.
  • Cannabis or CBD Use: Individuals who have used a cannabis or CBD product(s) within the last 3 months.
  • Residing in a State With CBD Restrictions: Residents of Idaho, Iowa, Missouri, South Dakota, Maine, and Nevada are not able to participate in this study.
  • Travel Plans: Plans to travel outside of the continental United States during the 4 week study intervention period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBD Capsule
Participants will take capsules containing 50 mg of CBD daily for 4 weeks.
Dietary supplement: Vantage Hemp CBD
Participants will consume 1 Vantage Hemp capsule, daily for 4 weeks.
Placebo Comparator: Placebo Capsule
Participants will take placebo capsules containing 0 mg of CBD daily for 4 weeks.
Dietary supplement: Vantage Hemp Placebo Capsule
Vantage Hemp Placebo Capsule Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Veterans RAND 12 Item Health Survey single domains
Time Frame: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Veterans Health Survey RAND (VR-12). Two z scores are reported (Mental Component and Physical Component Scores)patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10
Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Change in General Anxiety Disorder Questionnaire Score
Time Frame: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
General Anxiety Disorder Questionnaire 7.The GAD-7 scale score ranges from 0 to 21 points. A higher score suggests higher levels of anxiety.
Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Change in Beck Depression Inventory Score
Time Frame: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Beck Depression Inventory (BDI). Highest score is 63, Lowest score is 0.The higher the score, the more presence of depression.
Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Change in Defense and Veterans Pain Rating Scale Score
Time Frame: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Defense and Veterans Pain Rating Scale. Each item is scored 0 (no pain) - 10 (pain as bad as it can be). The higher the score indicates higher levels of pain.
Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Change in Pittsburg Sleep Quality Index Score
Time Frame: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Pittsburg Sleep Quality Index. Scores for each question range from 0-3. Higher scores indicating lower sleep quality.
Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Northern Colorado

Investigators

  • Principal Investigator: Laura Stewart, PhD, University of Northern Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2302048298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will become available when the study is published and will be available for 3 years.

IPD Sharing Time Frame

Data will become available when the study is published and will be available for 3 years.

IPD Sharing Access Criteria

Data (without subject ID numbers) will be shared upon email request laura.stewart@unco.edu.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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