NCT04267679

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2 anxiety

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

February 6, 2020

Last Update Submit

December 17, 2020

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (3)

  • Perception of change

    12 weeks

  • Protocol Compliance

    12 weeks

  • Sleep quality

    12 weeks

Study Arms (1)

Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol

Interventions

CannabidiolDRUG

25 mg full-spectrum CBD soft gel capsules

Cannabidiol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 13, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 19, 2020

Record last verified: 2020-12