Cannabidiol for Anxiety

Anxiety Clinical Trial

Official title:

Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04267679
• Other study ID #: GL-2020
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: CB2 Insights
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Drug:
• Cannabidiol
25 mg full-spectrum CBD soft gel capsules

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CB2 Insights	Green Lotus Hemp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalized Anxiety Disorder 7-item scale	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.	12 weeks
Secondary	Perception of change	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.	12 weeks
Secondary	Protocol Compliance	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.	12 weeks
Secondary	Sleep quality	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.	12 weeks