Cannabidiol for Anxiety

Phase 2

Withdrawn

• Conditions: Anxiety
• Interventions: Drug: Cannabidiol

• Registration Number: NCT04267679
• Lead Sponsor: CB2 Insights

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-13
• Study Start: 2020-03-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.