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Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05023759
Recruitment Status : Completed
First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Formula30A LLC

Brief Summary:
Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an effective treatment for anxiety-related symptoms while lacking the severity of adverse effects seen with other medications. Given the wide availability of products containing CBD on the market today, from tinctures to coffee additives, and the undetermined potential for drug-to-drug interactions, medical supervision of CBD intake and formulation-specific clinical research is necessary. Therefore this study aimed to observe the effects of a specific hemp-derived full spectrum CBD formula on anxiety-related symptoms in a group of volunteers. The investigators will examine the self-reported anxiety symptoms in relation to use of a specific CBD formulation (25mg solvent-free full spectrum CBD capsules) in a cohort of adults diagnosed with generalized anxiety disorder. This open-label, cohort study will be conducted at six clinic sites in the United States (including Puerto Rico) from June 2020 through October 2020. The six physicians recruited to participate in the study were each actively prescribing CBD in their practices and were actively caring for patients with anxiety symptoms. Anxiety levels will be measured in enrolled participants diagnosed with generalized anxiety disorder each week for a period of eight weeks using the Generalized Anxiety Disorder 7-Item Scale (GAD7). Participants will also be instructed to take a daily 25mg capsule of CBD. The investigators hypothesize that this formula, when carefully developed and administered by a healthcare professional, will significantly reduce anxiety symptoms.

Condition or disease Intervention/treatment
Generalized Anxiety Disorder Dietary Supplement: Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anxiety Symptoms in Relation to Use of Hemp-Derived, Full Spectrum Cannabidiol (CBD): a Cohort Study
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol


Intervention Details:
  • Dietary Supplement: Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules
    Formula30A Full Spectrum Hemp-Derived Cannabidiol (CBD) 25mg Capsules taken once daily for 8 weeks.


Primary Outcome Measures :
  1. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 8 weeks [ Time Frame: Measured at 8 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.



Secondary Outcome Measures :
  1. Participant Clinical Interview with Medical Provider [ Time Frame: Measured at 4 weeks after enrollment ]
  2. Participant Clinical Interview with Medical Provider [ Time Frame: Measured at 8 weeks after enrollment ]

Other Outcome Measures:
  1. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 1 week [ Time Frame: Measured at 1 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.


  2. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 2 week [ Time Frame: Measured at 2 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.


  3. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 3 weeks [ Time Frame: Measured at 3 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.


  4. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 4 weeks [ Time Frame: Measured at 4 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.


  5. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 5 weeks [ Time Frame: Measured at 5 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.


  6. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 6 weeks [ Time Frame: Measured at 6 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.


  7. Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 7 weeks [ Time Frame: Measured at 7 weeks after baseline ]

    The Generalized Anxiety Disorder 7-Item (GAD7) score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.

    The minimum score is 0 and the maximum score is 21, with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study conducted at six clinic sites in the United States, primarily Texas and Puerto Rico, from June 2020 through October 2020. Patients with a varying range of anxiety symptoms, who are current patients of the participating clinics and are who diagnosed with generalized anxiety disorder, will be eligible to enroll in the study.
Criteria

Inclusion Criteria:

  • Age between 21 and 85 years old.
  • Research participants of both sexes.
  • Good health conditions and without conditions that characterize them as belonging to the risk groups associated with adverse reactions to the product ingredients.
  • Research participants with the potential to become pregnant may be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective.
  • Signature of the Free and Informed Consent Form.

Exclusion Criteria:

  • Initiation of or changes in use of medication or therapies in the past 2 weeks of start of study.
  • Pregnancy or breastfeeding.
  • History of hepatic compromise with transaminases of 2 times the upper limit of normal or cirrhosis.
  • Diagnosis of Bi-Polar disorder, Schizophrenia or Suicidal Ideation.
  • Current use of recreational marijuana, medical marijuana, or other CBD formulations.
  • History of any substance or alcohol abuse.
  • Current use of High Dose or Extended-Release Narcotics.
  • Patients diagnosed with sleep apnea.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023759


Locations
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United States, Texas
NP Care Clinic
Denton, Texas, United States, 76201
Dr. Michael Jelinek, MD
Edinburg, Texas, United States, 78539
Modern Medicine
Forney, Texas, United States, 75126
Destination Health
Southlake, Texas, United States, 76092
Melville Medicine
Southlake, Texas, United States, 76092
Puerto Rico
Dr. Jenaro Velez, MD
Ceiba, Puerto Rico, 00735
Sponsors and Collaborators
Formula30A LLC
Publications:
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Responsible Party: Formula30A LLC
ClinicalTrials.gov Identifier: NCT05023759    
Other Study ID Numbers: F30A-CBD-GAD2020
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Starting 6 months after publication.
Access Criteria: IPD and additional supporting information shared upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Formula30A LLC:
cannabidiol
endocannabinoid system
CBD
cannabis
anxiety
generalized anxiety disorder
cannabinoids
endocannabinoids
GAD7
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Cannabidiol
Anticonvulsants