Clinical trial NCT05023759: Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)
Official title: Anxiety Symptoms in Relation to Use of Hemp-Derived, Full Spectrum Cannabidiol (CBD): a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Generalized Anxiety Disorder
Keywords: cannabidiol
endocannabinoid system
CBD
cannabis
anxiety
generalized anxiety disorder
cannabinoids
endocannabinoids
GAD7
Lead sponsor: Formula30A LLC
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 8 weeks
timeFrame: Measured at 8 weeks after baseline
Secondary outcomes:
measure: Participant Clinical Interview with Medical Provider
timeFrame: Measured at 4 weeks after enrollment
measure: Participant Clinical Interview with Medical Provider
timeFrame: Measured at 8 weeks after enrollment
Other outcomes:
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 1 week
timeFrame: Measured at 1 weeks after baseline
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 2 week
timeFrame: Measured at 2 weeks after baseline
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 3 weeks
timeFrame: Measured at 3 weeks after baseline
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 4 weeks
timeFrame: Measured at 4 weeks after baseline
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 5 weeks
timeFrame: Measured at 5 weeks after baseline
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 6 weeks
timeFrame: Measured at 6 weeks after baseline
measure: Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 7 weeks
timeFrame: Measured at 7 weeks after baseline
Locations:
city: Denton
country: United States
facility: NP Care Clinic
state: Texas
city: Edinburg
country: United States
facility: Dr. Michael Jelinek, MD
state: Texas
city: Forney
country: United States
facility: Modern Medicine
state: Texas
city: Southlake
country: United States
facility: Destination Health
state: Texas
city: Southlake
country: United States
facility: Melville Medicine
state: Texas
city: Ceiba
country: Puerto Rico
facility: Dr. Jenaro Velez, MD
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.