Clinical trial

Sublingual Cannabidiol for Anxiety

Name

2015P000959

Description

This is an open-label to double-blind study evaluating the effects of cannabidiol (CBD) for the treatment of anxiety in adults. Participants will use a sublingual (under-the-tongue) solution of whole plant-derived CBD or placebo three times daily for four weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. In addition, cognitive function and measures of quality of life, sleep, and general health will be assessed at baseline and the post-treatment final visit.

Trial arms

Trial start

2018-08-14

Estimated PCD

2025-08-01

Trial end

2025-08-01

Status

Recruiting

Phase

Early phase I

Treatment

Full-Spectrum Cannabidiol

Full-Spectrum Cannabidiol; total daily dose of 30 mg.

Arms:

Full-Spectrum Cannabidiol

Single-Compound Cannabidiol

Single-Compound Cannabidiol; total daily dose of 30 mg.

Arms:

Single-Compound Cannabidiol

Placebo

Placebo solution.

Arms:

Placebo

Size

Primary endpoint

Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)

Week 1, Week 2, Week 3, Week 4

Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)

Week 1, Week 2, Week 3, Week 4

Change from Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)

Week 1, Week 2, Week 3, Week 4

Change from Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)

Week 1, Week 2, Week 3, Week 4

Eligibility criteria

Inclusion Criteria: * 18 or older * Native English speaker or acquired English prior to age 5 * Provides informed consent * Endorses moderate or severe anxiety at the screening visit Exclusion Criteria: * Non-native English speakers * Estimated IQ \< 75 * Pregnancy * Presence of serious medical illness, including liver or kidney disease, neurological disorder, or certain psychiatric disorders * History of head injury or loss of consciousness \>5 minutes * Current use of cannabis or cannabinoid products \>1x/month

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 97, 'type': 'ESTIMATED'}}

Updated at

2024-03-08

1 organization

2 products

1 drug

1 indication

Organization

Staci Gruber, Ph.D.

Product

Full-Spectrum Cannabidiol

Indication

Anxiety

Product

Cannabidiol

Drug

Varlilumab