Sublingual Cannabidiol for Anxiety
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|ClinicalTrials.gov Identifier: NCT02548559|
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Drug: Full-Spectrum Cannabidiol Drug: Single-Compound Cannabidiol Drug: Placebo||Phase 2|
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 phases. Phase 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. Phase 1 of the study was completed in early 2020.
Phase 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 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. We are currently recruiting for Phase 2 of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Sublingual Cannabidiol for Anxiety|
|Actual Study Start Date :||August 14, 2018|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Full-Spectrum Cannabidiol
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
Full-Spectrum Cannabidiol; total daily dose of 30 mg.
Experimental: Single-Compound Cannabidiol
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
Single-Compound Cannabidiol; total daily dose of 30 mg.
Placebo Comparator: Placebo
1 ml of placebo solution administered three times per day (TID) for four weeks.
- 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.
- 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.
- 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, and differentiates between the more temporary condition of "state" anxiety and the more general quality of "trait" anxiety. It will be given on a weekly basis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548559
|Contact: Ashley Lambros, B.S.||617-855-3338||CBDstudy@mclean.harvard.edu|
|United States, Massachusetts|
|McLean Hospital Brain Imaging Center||Recruiting|
|Belmont, Massachusetts, United States, 02478-9106|
|Contact: Staci Gruber, PhD 617-855-2762 email@example.com|
|Principal Investigator: Staci A Gruber, Ph.D.|
|Sub-Investigator: David P Olson, M.D., Ph.D.|
|Sub-Investigator: Scott E Lukas, Ph.D.|
|Principal Investigator:||Staci Gruber, PhD.||Mclean Hospital|