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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules | Dietary Supplement | Formula30A Full Spectrum Hemp-Derived Cannabidiol (CBD) 25mg Capsules taken once daily for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 8 weeks | 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. | Measured at 8 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Clinical Interview with Medical Provider | Measured at 4 weeks after enrollment | |
| Participant Clinical Interview with Medical Provider | Measured at 8 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 1 week | 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NP Care Clinic | Denton | Texas | 76201 | United States | ||
| Dr. Michael Jelinek, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31866386 | Background | Skelley JW, Deas CM, Curren Z, Ennis J. Use of cannabidiol in anxiety and anxiety-related disorders. J Am Pharm Assoc (2003). 2020 Jan-Feb;60(1):253-261. doi: 10.1016/j.japh.2019.11.008. Epub 2019 Dec 19. | |
| 26341731 | Background | Blessing EM, Steenkamp MM, Manzanares J, Marmar CR. Cannabidiol as a Potential Treatment for Anxiety Disorders. Neurotherapeutics. 2015 Oct;12(4):825-36. doi: 10.1007/s13311-015-0387-1. |
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All IPD that underlie results in a publication.
Starting 6 months after publication.
IPD and additional supporting information shared upon request.
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D002189 | Marijuana Abuse |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Measured at 1 weeks after baseline |
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 2 week | 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. | Measured at 2 weeks after baseline |
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 3 weeks | 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. | Measured at 3 weeks after baseline |
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 4 weeks | 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. | Measured at 4 weeks after baseline |
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 5 weeks | 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. | Measured at 5 weeks after baseline |
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 6 weeks | 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. | Measured at 6 weeks after baseline |
| Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 7 weeks | 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. | Measured at 7 weeks after baseline |
| Edinburg |
| Texas |
| 78539 |
| United States |
| Modern Medicine | Forney | Texas | 75126 | United States |
| Destination Health | Southlake | Texas | 76092 | United States |
| Melville Medicine | Southlake | Texas | 76092 | United States |
| Dr. Jenaro Velez, MD | Ceiba | 00735 | Puerto Rico |
| 20829306 | Background | Crippa JA, Derenusson GN, Ferrari TB, Wichert-Ana L, Duran FL, Martin-Santos R, Simoes MV, Bhattacharyya S, Fusar-Poli P, Atakan Z, Santos Filho A, Freitas-Ferrari MC, McGuire PK, Zuardi AW, Busatto GF, Hallak JE. Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. J Psychopharmacol. 2011 Jan;25(1):121-30. doi: 10.1177/0269881110379283. Epub 2010 Sep 9. |
| 28861514 | Background | Iffland K, Grotenhermen F. An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies. Cannabis Cannabinoid Res. 2017 Jun 1;2(1):139-154. doi: 10.1089/can.2016.0034. eCollection 2017. |
| 16717171 | Background | Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. |