Anxiety
Conditions
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.
Interventions
DRUGCannabidiol
25 mg full-spectrum CBD soft gel capsules
Sponsors
Green Lotus Hemp
CB2 Insights
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder 7-item scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Perception of change | 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 | 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 | 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. |
Outcome results
None listed