An interventional study of Vantage Hemp CBD and Vantage Hemp Placebo Capsule in Healthy, sponsored by University of Northern Colorado. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by University of Northern Colorado · Not applicable, Interventional, and Prevention
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.
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.
1,045 studies on the registry are indexed under Psychological Well-Being; 509 are open to participants now.
This study's planned enrollment of 100 is below the median of 113 across 888 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Northern Colorado is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants will take capsules containing 50 mg of CBD daily for 4 weeks.
Dietary Supplement: Vantage Hemp CBD
Participants will take placebo capsules containing 0 mg of CBD daily for 4 weeks.
Dietary Supplement: Vantage Hemp Placebo Capsule
Participants will consume 1 Vantage Hemp capsule, daily for 4 weeks.
Vantage Hemp Placebo Capsule Intervention
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention
Plan to share: Yes — Data will become available when the study is published and will be available for 3 years.
Supporting information: Study protocol
Time frame: Data will become available when the study is published and will be available for 3 years.
Access criteria: Data (without subject ID numbers) will be shared upon email request laura.stewart@unco.edu.
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Dec 2024, 19 months after the start.
Of 650 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 19 months is close to that.
Counting every sponsor, half of 671 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Northern Colorado