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Withdrawn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
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Sponsor:
CB2 Insights
Collaborator:
Green Lotus Hemp
Information provided by (Responsible Party):
CB2 Insights
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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
Arm | Intervention/treatment |
---|---|
Experimental: Cannabidiol
Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks.
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Drug: Cannabidiol
25 mg full-spectrum CBD soft gel capsules |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
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
- Male or female patients 18 years of age or older with a GAD-7 score of 10 or greater
- Presenting to a participating clinic for initial evaluation for a medical cannabis card
- Willingness to abstain from the use of all other cannabis products for the trial period (3 months)
- Not pregnant or planning to become pregnant during the trial period (3 months)
- Not breastfeeding or planning to breastfeed during the trial period (3 months)
- No history of cannabis use within 4 weeks of enrollment
- No history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder)
- No history of lifetime daily cannabis use
- No family history of psychosis (e.g., bipolar disorder or schizophrenia)
- No history of adverse reactions to cannabis
- No recent changes to prescribed anxiety medications (within the last 1 month)
- Provision of informed consent
No Contacts or Locations Provided
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Anxiety Disorders Mental Disorders Cannabidiol Anticonvulsants |