Sublingual Cannabidiol for Anxiety
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Study Overview
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.
Detailed Description
Cannabis has been used for medicinal purposes across many cultures for a range of disorders for thousands of years. The plant is comprised of a variety of components, such as phytocannabinoids, which include (among others) the major intoxicating constituent of cannabis, delta-9 tetrahydrocannabinol (THC), and cannabidiol (CBD), a major non-intoxicating constituent of cannabis. Increasing evidence indicates that CBD in particular may have significant medicinal properties and benefits; experimental studies in both animals and humans have demonstrated that CBD can act as an anticonvulsant, antipsychotic, and muscle relaxant. Several studies have demonstrated that CBD produces acute anxiolytic effects in animals and humans, although thus far no clinical trials of CBD have been conducted in patients with anxiety. As a growing number of states are legalizing medical cannabis, a gap exists in the scientific literature regarding the effects of CBD on anxiety.
This investigation is composed of two stages. Stage 1 is comprised of a four-week, open-label clinical trial of a high-CBD containing compound in individuals with anxiety. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, participants will come to the hospital for a baseline/screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, and cognitive assessments. Enrolled participants will be given CBD solution to use for the duration of the study; participants will be instructed to self-administer 1 milliliter (ml) of the tincture under the tongue three times per day for four weeks. Throughout the treatment period, participants will return to the hospital on a weekly basis to complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments. Stage 1 of the study was completed in early 2020.
Stage 2 of the study is a double-blind clinical trial of this solution in patients with anxiety. This double-blind trial began after the open-label trial was completed. In the same manner as the open-label trial, participants will be pre-screened by phone, and approved participants will come to the hospital for a baseline/screening visit to complete a structured clinical interview, questionnaires, and cognitive assessments. Eligible participants will also have the option to complete an hour-long MRI scan at the baseline and final visits. Enrolled participants will receive either full-spectrum CBD solution, single-compound CBD solution, or placebo solution to self-administer throughout the four week treatment period, as described above. Participants will return to the hospital weekly during the treatment period to complete questionnaires about their mood and quality of life. Participants in this stage of the study will also return for a final visit after four weeks of treatment to complete additional questionnaires, cognitive assessments, and an optional hour-long MRI scan. We are currently recruiting for Stage 2 of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single-Compound Cannabidiol
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Intervention: Single-Compound Cannabidiol (Drug)
Full-Spectrum Cannabidiol
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Intervention: Full-Spectrum Cannabidiol (Drug)
Placebo
1 ml of placebo solution administered three times per day (TID) for four weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Time Frame: Week 1, Week 2, Week 3, Week 4
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 (higher scores indicating more anxiety).
Change from Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Week 1, Week 2, Week 3, Week 4
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 (higher scores indicating more anxiety).
Change from Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame: Week 1, Week 2, Week 3, Week 4
This self-report measure is comprised of two 20-item scales, 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.
Change from Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)
Time Frame: Week 1, Week 2, Week 3, Week 4
This observer-rating 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.
Secondary Outcomes
- Change from Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)(Week 1, Week 2, Week 3, Week 4)
- Change from Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)(Week 1, Week 4)
- Change from Baseline in Mood Measured by the Profile of Mood States (POMS)(Week 1, Week 2, Week 3, Week 4)
- Change from Baseline in Sexual Health Measured by the Arizona Sexual Experience Scale (ASEX)(Week 1, Week 4)
- Change from Baseline on the Wisconsin Card Sort Test (WCST)(Week 1, Week 4)
- Change from Baseline on the Letter-Number Sequencing (LNS) Subtest of the Wechsler Adult Intelligence Scale(Week 1, Week 4)
- Change from Baseline on the Digit Symbol Substitution Test (DSST) of the Wechsler Adult Intelligence Scale(Week 1, Week 4)
- Change from Baseline on the Multi-Source Interference Task (MSIT)(Week 1, Week 4)
- Change from Baseline on the Controlled Oral Word Association Test (COWAT)(Week 1, Week 4)
- Change from Baseline in Quality of Life Measured by the 36-Item Short Form (SF-36)(Week 1, Week 4)
- Patient's Global Impression of Change (PGIC) Scale Score at Week 4(Week 4)
- Change from Baseline on the Rey Auditory Verbal Learning Test (RAVLT)(Week 1, Week 4)
- Change from Baseline in Mood Assessed by the Positive and Negative Affect Scale (PANAS)(Week 1, Week 2, Week 3, Week 4)
- Change from Baseline on Stroop Color-Word Test(Week 1, Week 4)
- Change from Baseline on Trail Making Test(Week 1, Week 4)
Investigators
Staci Gruber, Ph.D.
Director, Cognitive and Clinical Neuroimaging Core
Mclean Hospital