HealthyNCT05850754
4 Week Veterans Cannabidiol Intervention
A study testing Vantage Hemp CBD in people with Healthy, run by University of Northern Colorado at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vantage Hemp CBD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Northern Colorado
Greeley, Colorado, 80639
About this study
Official title: 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.
Read the 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
- Being tested
- Vantage Hemp CBD, Vantage Hemp Placebo Capsule
- Keywords
- cannabidiol, veterans, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vantage Hemp CBDDietary supplement
Participants will consume 1 Vantage Hemp capsule, daily for 4 weeks.
Vantage Hemp Placebo CapsuleDietary supplement
Vantage Hemp Placebo Capsule Intervention
| Study group | Role | What they receive |
|---|---|---|
| CBD Capsule | Experimental | Participants will take capsules containing 50 mg of CBD daily for 4 weeks. Receives: Dietary Supplement: Vantage Hemp CBD |
| Placebo Capsule | Placebo comparator | Participants will take placebo capsules containing 0 mg of CBD daily for 4 weeks. Receives: Dietary Supplement: Vantage Hemp Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Veterans RAND 12 Item Health Survey single domains
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
Measured: 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
General Anxiety Disorder Questionnaire 7.The GAD-7 scale score ranges from 0 to 21 points. A higher score suggests higher levels of anxiety.
Measured: 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
Beck Depression Inventory (BDI). Highest score is 63, Lowest score is 0.The higher the score, the more presence of depression.
Measured: 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
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.
Measured: 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
Pittsburg Sleep Quality Index. Scores for each question range from 0-3. Higher scores indicating lower sleep quality.
Measured: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomly assigned to 1 of 2 groups and followed throughout a 4 week intervention period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, University of Northern Colorado
- Investigators
- Laura Stewart, PhD, Principal investigator, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850754
- Sponsor's protocol ID
- 2302048298
- Status last verified
- May 2024
- First submitted
- 14 Mar 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will become available when the study is published and will be available for 3 years.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Veterans 4 Week Cannabidiol Intervention
- ClinicalTrials.gov ID
- NCT05850754
- Acronym / sponsor ID
- 2302048298
- Conditions
- Healthy
- Keywords
- cannabidiol, veterans, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study participants will be randomly assigned to 1 of 2 groups and followed throughout a 4 week intervention period.
| Arm | Type | Receives |
|---|---|---|
| CBD Capsule | Experimental | Dietary Supplement: Vantage Hemp CBDParticipants will take capsules containing 50 mg of CBD daily for 4 weeks. |
| Placebo Capsule | Placebo comparator | Dietary Supplement: Vantage Hemp Placebo CapsuleParticipants will take placebo capsules containing 0 mg of CBD daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vantage Hemp CBDParticipants will consume 1 Vantage Hemp capsule, daily for 4 weeks. | Dietary supplement | CBD Capsule |
| Vantage Hemp Placebo CapsuleVantage Hemp Placebo Capsule Intervention | Dietary supplement | Placebo Capsule |
Primary outcome
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
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will become available when the study is published and will be available for 3 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Stewart, PhD principal investigator
University of Northern Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vantage Hemp CBD in people with Healthy, run by University of Northern Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.