Sublingual Cannabidiol for Anxiety

NCT02548559 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2015P000959
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (4)

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

  The BAI is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 to 3, with total scores ranging from 0 to 63 (higher scores indicating more anxiety).

  4 Weeks

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

  The OASIS is a brief 5-item measure used to evaluate the functional impairment cause by anxiety that will be given on a weekly basis; the frequency and intensity of anxiety, as well as the degree of avoidance and interference with work and social function are rated on a scale of 0 to 4; total scores range from 0 to 20 (higher scores indicating more anxiety).

  4 Weeks

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

  This self-report measure is comprised of two 20-item scales (STAI-State and STAI-Trait), with a range of four possible responses from 1 to 4 (higher scores indicating more anxiety), and differentiates between the more temporary condition of "state" anxiety and the more general quality of "trait" anxiety. Total scores on each scale range from 20-80, with higher scores indicating more anxiety.

  4 Weeks

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

  This observer-rated 14-item scale is administered in the form of an interview, and allows information from multiple sources to influence ratings (i.e. subject report, examiner's observation), and has been shown to be reliable index of clinical state. A range of 5 possible responses (0-4, not present-very severe) are possible for each item, with a total score range of 0-56 with higher scores indicating more anxiety.

  4 Weeks

Secondary Outcomes (3)

• Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)

  4 Weeks

• Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

  4 Weeks

• Patient's Global Impression of Change (PGIC) Scale Score at Week 4

  Week 4

Study Arms (3)

Full-Spectrum Cannabidiol

EXPERIMENTAL

1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.

Drug: Full-Spectrum Cannabidiol

Single-Compound Cannabidiol

EXPERIMENTAL

1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.

Drug: Single-Compound Cannabidiol

Placebo

PLACEBO COMPARATOR

1 ml of placebo solution administered three times per day (TID) for four weeks.

Drug: Placebo

Interventions

Full-Spectrum Cannabidiol DRUG

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

Full-Spectrum Cannabidiol

Single-Compound Cannabidiol DRUG

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

Single-Compound Cannabidiol

Placebo DRUG

Placebo solution.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Native English speaker or acquired English prior to age 5
• Provides informed consent
• Endorses moderate or severe anxiety at the screening visit

You may not qualify if:

• 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

Sponsors & Collaborators

• Staci Gruber, Ph.D.: lead

Study Sites (1)

McLean Hospital Brain Imaging Center

Belmont, Massachusetts, 02478-9106, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Staci Gruber, Ph.D.
• Organization: McLean Hospital

gruber@mclean.harvard.edu

617-855-2762

Study Officials

• Staci Gruber, PhD.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cognitive and Clinical Neuroimaging Core

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 14, 2015
• Study Start: August 14, 2018
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Locations

US (1)