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Cannabidiol for Anxiety

NCT ID: NCT04267679

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cannabidiol

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

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

25 mg full-spectrum CBD soft gel capsules

Interventions

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Cannabidiol

25 mg full-spectrum CBD soft gel capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Lotus Hemp

UNKNOWN

Sponsor Role collaborator

CB2 Insights

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GL-2020

Identifier Type: -

Identifier Source: org_study_id