Anxiety
Conditions
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.
Interventions
DRUGFull-Spectrum Cannabidiol
Full-Spectrum Cannabidiol; total daily dose of 30 mg.
DRUGSingle-Compound Cannabidiol
Single-Compound Cannabidiol; total daily dose of 30 mg.
DRUGPlacebo
Placebo solution.
Sponsors
Staci Gruber, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) | 4 Weeks | 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). |
| Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS) | 4 Weeks | 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). |
| Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI) | 4 Weeks | 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. |
| Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A) | 4 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI) | 4 Weeks | The BDI is a 21 item-self-report measure that can be used to assess the severity of depression. Each item on the BDI relates to a symptom of depression and is rated by the subject using a 0-3 scale (higher scores indicating increased severity), with a total score range of 0-63. |
| Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 4 Weeks | The PSQI contains 19 self-rated questions that assess sleep quality and disturbance over the previous 1-month period. The 19 items yield seven component scores such as sleep latency, sleep duration, and daytime dysfunction, which are then summed to generate a global score ranging from 0-21 (higher scores indicating lower sleep quality). |
| Patient's Global Impression of Change (PGIC) Scale Score at Week 4 | Week 4 | The PGIC is a single-question, 7-point scale depicting a patient's rating of overall improvement since baseline from "very much worse" (score=1) to "very much improved" (score=7). Higher scores indicate greater improvement. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStaci Gruber, PhD.
Mclean Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.83 Years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 10 Participants |
| Years of Education | 16.03 Years STANDARD_DEVIATION 2.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 8 / 34 | 2 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 34 | 0 / 6 | 0 / 6 |
Outcome results
None listed