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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | 1 ml of placebo solution administered three times per day (TID) for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-Spectrum Cannabidiol | Drug | Full-Spectrum Cannabidiol; total daily dose of 30 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI) | 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. | 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Staci Gruber, PhD. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital Brain Imaging Center | Belmont | Massachusetts | 02478-9106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Full-Spectrum Cannabidiol | 1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. |
| FG001 | Single-Compound Cannabidiol | 1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. |
| FG002 | Placebo | 1 ml of placebo solution administered three times per day (TID) for four weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1: Open-Label |
|
| ||||||||||||||||||
| Stage 2: Double-Blind |
|
Stages 1 and 2 are reported combined throughout the record.
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| ID | Title | Description |
|---|---|---|
| BG000 | Full-Spectrum Cannabidiol | 1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. |
| BG001 | Single-Compound Cannabidiol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Study completers were analyzed from both Stage 1 and Stage 2. | Posted | Mean | Standard Deviation | Score | 4 Weeks |
|
From enrollment until end of follow-up, up to 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full-Spectrum Cannabidiol | 1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insertion site pain at site of blood draw | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Staci Gruber, Ph.D. | McLean Hospital | 617-855-2762 | gruber@mclean.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2025 | Mar 4, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Single-Compound Cannabidiol | Drug | Single-Compound Cannabidiol; total daily dose of 30 mg. |
|
| Placebo | Drug | Placebo solution. |
|
| Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 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). | 4 Weeks |
| Patient's Global Impression of Change (PGIC) Scale Score at 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. | Week 4 |
| NOT COMPLETED |
|
|
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
| BG002 | Placebo | 1 ml of placebo solution administered three times per day (TID) for four weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Years of Education | Mean | Standard Deviation | Years |
|
| OG002 | Placebo | 1 ml of placebo solution administered three times per day (TID) for four weeks. |
|
|
|
| Primary | 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). | Participants who completed the trial were included in analyses (Stage 1 and Stage 2). | Posted | Mean | Standard Deviation | Score | 4 Weeks |
|
|
|
|
| Primary | 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. | Participants who completed the trial were included in analyses (Stage 1 and Stage 2). | Posted | Mean | Standard Deviation | Score | 4 Weeks |
|
|
|
|
| Primary | 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. | Participants who completed the trial were included in analyses (Stage 1 and Stage 2). | Posted | Mean | Standard Deviation | Score | 4 Weeks |
|
|
|
|
| Secondary | Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI) | 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. | Participants who completed the trial were included in analyses (Stage 1 and Stage 2) | Posted | Mean | Standard Deviation | Score | 4 Weeks |
|
|
|
|
| Secondary | Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 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). | Participants who completed the trial were included in analyses (Stage 1 and Stage 2). | Posted | Mean | Standard Deviation | Score | 4 Weeks |
|
|
|
|
| Secondary | Patient's Global Impression of Change (PGIC) Scale Score at 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. | Participants who completed the trial were included in analyses (Stage 1 and Stage 2). | Posted | Median | Inter-Quartile Range | Score | Week 4 |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 8 |
| 34 |
| EG001 | Single-Compound Cannabidiol | 1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Placebo | 1 ml of placebo solution administered three times per day (TID) for four weeks. | 0 | 6 | 0 | 6 | 1 | 6 |
| Dry mouth/throat discomfort | General disorders | Systematic Assessment |
|
| Stomachache | Gastrointestinal disorders | Systematic Assessment |
|
| Lassitude | General disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment | Participant reported palpitations in the context of a panic attack. |
|
| Panic attack symptoms | Psychiatric disorders | Systematic Assessment |
|
| Feeling faint after blood draw | General disorders | Systematic Assessment |
|
| Feeling "heady" | Psychiatric disorders | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Derealization | Psychiatric disorders | Systematic Assessment | Patient reported this feeling when she used another cannabis product concurrently with the study product, and was subsequently disqualified as other cannabinoid use was prohibited. |
|
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|
| t-test, 1 sided |
| 0.029 |
| Other |
Within-group change over time. |
These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| t-test, 1 sided | 0.009 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
|
| STAI-Trait Baseline |
|
| STAI-Trait Week 4 |
|
| STAI-State | t-test, 1 sided | 0.025 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| STAI-State | t-test, 1 sided | 0.026 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| STAI-Trait | t-test, 1 sided | <0.001 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| STAI-Trait | t-test, 1 sided | 0.021 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| t-test, 1 sided | 0.010 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
|
| t-test, 1 sided |
| 0.001 |
| Other |
Within-group change over time. |
These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| t-test, 1 sided | 0.134 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
|
| t-test, 1 sided |
| 0.007 |
| Other |
Within-group change over time. |
These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
| t-test, 1 sided | 0.019 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x5) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over all study timepoints (Baseline, Week 1, Week 2, Week 3, Week 4). |
|
| t-test, 1 sided |
| 0.015 |
| Other |
Within-group change over time. |
These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x2) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over study timepoints (Baseline, Week 4). |
| t-test, 1 sided | 0.214 | Other | Within-group change over time. | These are preliminary paired t-tests assessing change from baseline to Week 4 within each treatment group individually. Additional linear mixed models (LMMs; 3x2) will be conducted assessing differences in treatment groups (full-spectrum vs. isolate vs. placebo) over study timepoints (Baseline, Week 4). |