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Generalized Anxiety DisorderNCT05023759

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

An observational study of Generalized Anxiety Disorder, run by Formula30A LLC at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules
Type of treatment
Pill or oral medicine
How many people
30 participants
Where
6 sitesin 2 countries
Study dates
1 Jun 2020to 31 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • NP Care Clinic

    Denton, Texas, 76201

  • Dr. Michael Jelinek, MD

    Edinburg, Texas, 78539

  • Modern Medicine

    Forney, Texas, 75126

  • Destination Health

    Southlake, Texas, 76092

  • Melville Medicine

    Southlake, Texas, 76092

Other trials in United States

Puerto Rico1 site

  • Dr. Jenaro Velez, MD

    Ceiba, 00735

Other trials in Puerto Rico

About this study

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

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.

Being tested
Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules
Keywords
cannabidiol, endocannabinoid system, CBD, cannabis, anxiety, generalized anxiety disorder, cannabinoids, endocannabinoids, GAD7
Medical subject headings
Generalized Anxiety Disorder, Marijuana Abuse, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formula30A Full Spectrum Hemp Cannabidiol 25mg CapsulesDietary supplement

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured at 8 weeks after baseline

Secondary outcomes (2)

  1. Participant Clinical Interview with Medical Provider

    Measured: Measured at 4 weeks after enrollment

  2. Participant Clinical Interview with Medical Provider

    Measured: Measured at 8 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start1 Jun 2020
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05023759
Sponsor's protocol ID
F30A-CBD-GAD2020
Status last verified
Aug 2021
First submitted
17 Aug 2021
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication.

Publications

  • 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.

    PubMed 31866386

  • 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.

    PubMed 26341731

  • 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.

    PubMed 20829306

  • 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.

    PubMed 28861514

  • 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.

    PubMed 16717171

Questions about this trial

What is this clinical trial studying?

An observational study of Generalized Anxiety Disorder, run by Formula30A LLC at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Generalized Anxiety Disorder 7-Item Scale (GAD7) Score at 8 weeks (time frame: Measured at 8 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05023759, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.

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