Sublingual Cannabidiol for Anxiety
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ClinicalTrials.gov Identifier: NCT02548559 |
Recruitment Status
:
Not yet recruiting
First Posted
: September 14, 2015
Last Update Posted
: December 18, 2017
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Tracking Information | |||||
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First Submitted Date ICMJE | September 4, 2015 | ||||
First Posted Date ICMJE | September 14, 2015 | ||||
Last Update Posted Date | December 18, 2017 | ||||
Estimated Study Start Date ICMJE | March 2018 | ||||
Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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, and will be given to participants on a weekly basis.
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Original Primary Outcome Measures ICMJE |
Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) [ Time Frame: One week ] 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, and will be given to participants on a weekly basis.
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Change History | Complete list of historical versions of study NCT02548559 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sublingual Cannabidiol for Anxiety | ||||
Official Title ICMJE | Sublingual Cannabidiol for Anxiety | ||||
Brief Summary | This study evaluates the effects of cannabidiol (CBD) for the treatment of anxiety in adults certified for medical marijuana. Participants will use a sublingual (under-the-tongue) tincture of whole plant derived CBD 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, general health, and multimodal neuroimaging 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 dating as far back as 2700 B.C. The plant is comprised of a variety of components, including phytocannabinoids that act on CB1 and CB2 receptors. Numerous phytocannabinoids are present in cannabis, including the major psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), which acts as a CB1 receptor agonist. Another phytocannabinoid, cannabidiol (CBD), is a major non-psychoactive constituent of cannabis and is only a partial agonist at CB1 receptors. 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. CBD is often found in higher levels in products dispensed as medical marijuana relative to strains used primarily for recreational use. 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 marijuana, a gap exists in the scientific literature regarding the effects of CBD on anxiety. This investigation is composed of two phases. Phase 1 is comprised of a four-week, open label clinical trial of a high-CBD containing compound (22:1 CBD:THC) 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, cognitive assessments, and an hour-long MRI scan. Enrolled participants will be given tincture to use for the duration of the study; participants will be instructed to self-administer 2 milliliters (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, cognitive assessments, and another hour-long MRI scan. Phase 2 of the study is a double-blind clinical trial of this tincture in patients with anxiety. This double-blind trial will begin after the open-label trial has been 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 CBD tincture or placebo tincture 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 phase 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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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Anxiety | ||||
Intervention ICMJE | Drug: Cannabidiol
Cannabidiol; total daily dose of 28.08mg. |
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Study Arms | Experimental: Cannabidiol
2ml of sublingual cannabidiol tincture (4.68mg/ml CBD) administered three times per day (TID) for four weeks.
Intervention: Drug: Cannabidiol |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date | March 2019 | ||||
Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02548559 | ||||
Other Study ID Numbers ICMJE | 2015P000959 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Staci Gruber, Ph.D., McLean Hospital | ||||
Study Sponsor ICMJE | Staci Gruber, Ph.D. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Mclean Hospital | ||||
Verification Date | December 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |