Back to resultsCannabidiol for Anxiety
Primary Purpose
Anxiety
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cannabidiol
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cannabidiol
Arm Description
Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04267679
First Posted
February 6, 2020
Last Updated
December 17, 2020
Sponsor
CB2 Insights
Collaborators
Green Lotus Hemp
1. Study Identification
Unique Protocol Identification Number
NCT04267679
Brief Title
Cannabidiol for Anxiety
Official Title
Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped due to COVID-19 pandemic.
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CB2 Insights
Collaborators
Green Lotus Hemp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Description
25 mg full-spectrum CBD soft gel capsules
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder 7-item scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Perception of change
Description
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.
Time Frame
12 weeks
Title
Protocol Compliance
Description
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.
Time Frame
12 weeks
Title
Sleep quality
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Cannabidiol for Anxiety
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