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Cannabidiol for Anxiety

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ClinicalTrials.gov Identifier: NCT04267679
Recruitment Status : Withdrawn (Stopped due to COVID-19 pandemic.)
First Posted : February 13, 2020
Last Update Posted : December 19, 2020
Sponsor:
Collaborator:
Green Lotus Hemp
Information provided by (Responsible Party):
CB2 Insights

Study Description
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Brief Summary:
This pilot trial seeks to investigate the effect of 25 mg full-spectrum CBD soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. All participants will take CBD soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change.

Condition or disease Intervention/treatment Phase
Anxiety Drug: Cannabidiol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol
Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks.
 Drug: Cannabidiol
25 mg full-spectrum CBD soft gel capsules


Outcome Measures
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Primary Outcome Measures :
  1. Generalized Anxiety Disorder 7-item scale [ Time Frame: 12 weeks ]
    The Generalized Anxiety Disorder 7-item scale is one of the most frequently used, validated self-reported questionnaires that is used to screen for, diagnose, and assess severity of generalized anxiety disorder.


Secondary Outcome Measures :
  1. Perception of change [ Time Frame: 12 weeks ]
    Participants will complete the Patients' Global Impression of Change (PGIC) scale at each follow-up visit, which has been regarded as an important self-reported indicator of change.

  2. Protocol Compliance [ Time Frame: 12 weeks ]
    Participants will self-report their intervention compliance using a simple log that will be provided to them at their enrollment visit and will be asked to bring their CBD log to every follow-up visit. Participants will also self-report any medical cannabis or opioid usage.

  3. Sleep quality [ Time Frame: 12 weeks ]
    Participants will be asked whether they believe that the CBD intervention has impacted their sleep quality. They will be asked to complete a short 2-question survey.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Male or female patients 18 years of age or older with a GAD-7 score of 10 or greater
  2. Presenting to a participating clinic for initial evaluation for a medical cannabis card
  3. Willingness to abstain from the use of all other cannabis products for the trial period (3 months)
  4. Not pregnant or planning to become pregnant during the trial period (3 months)
  5. Not breastfeeding or planning to breastfeed during the trial period (3 months)
  6. No history of cannabis use within 4 weeks of enrollment
  7. No history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder)
  8. No history of lifetime daily cannabis use
  9. No family history of psychosis (e.g., bipolar disorder or schizophrenia)
  10. No history of adverse reactions to cannabis
  11. No recent changes to prescribed anxiety medications (within the last 1 month)
  12. Provision of informed consent
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: CB2 Insights
ClinicalTrials.gov Identifier: NCT04267679    
Other Study ID Numbers: GL-2020
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Epidiolex
Anticonvulsants