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NCT Number: NCT05023759

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

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Jenaro Velez, MD, Ceiba, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules

Dietary Supplement

Formula30A Full Spectrum Hemp-Derived Cannabidiol (CBD) 25mg Capsules taken once daily for 8 weeks.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Formula30A LLC

Industry

Registry information

Official study title

Anxiety Symptoms in Relation to Use of Hemp-Derived, Full Spectrum Cannabidiol (CBD): a Cohort Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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