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Recruitment Status : Withdrawn (Stopped due to COVID-19 pandemic.)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
Green Lotus Hemp
Information provided by (Responsible Party):
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks.
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.
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