## Protocol Section
### Identification Module
**NCT ID:** NCT04267679

**Brief Title:** Cannabidiol for Anxiety

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

#### Organization Study ID Info
**ID:** GL-2020
#### Organization
**Class:** OTHER
**Full Name:** CB2 Insights
### Status Module
#### Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-12-19

**Type:** ACTUAL

**Last Update Submit Date:** 2020-12-17

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-03-01

**Type:** ACTUAL

**Status Verified Date:** 2020-12

#### Study First Post Date
**Date:** 2020-02-13
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-06
**Study First Submit QC Date:** 2020-02-10
**Why Stopped:** Stopped due to COVID-19 pandemic.
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Green Lotus Hemp

#### Lead Sponsor

**Class:** OTHER

**Name:** CB2 Insights

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Anxiety

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks.

**Intervention Names:**

- Drug: Cannabidiol

**Label:** Cannabidiol

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cannabidiol

**Description:** 25 mg full-spectrum CBD soft gel capsules

**Name:** Cannabidiol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Generalized Anxiety Disorder 7-item scale

**Time Frame:** 12 weeks

#### Secondary Outcomes

**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.

**Measure:** Perception of change

**Time Frame:** 12 weeks

**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.

**Measure:** Protocol Compliance

**Time Frame:** 12 weeks

**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.

**Measure:** Sleep quality

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Intervention Browse Module - Ancestors

- ID: D000000927

- Term: Anticonvulsants

### Intervention Browse Module - Browse Branches

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5445

- Name: Cannabidiol

- Relevance: HIGH

- As Found: Sarcoma

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002185

- Term: Cannabidiol

### Misc Info Module

- Version Holder: 2024-05-24
