- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04286594
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
Study Overview
Detailed Description
This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived product in individuals with anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, no studies have conducted a clinical trial of a hemp-derived product in individuals who suffer from anxiety.
This investigation is composed of two phases. Phase 1 is comprised of a six-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution in individuals with anxiety (n=12). 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 study product to use for the duration of the study; participants will be instructed to self-administer the solution under the tongue twice daily for six weeks. Throughout the treatment period, participants will complete short in-person or phone visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after six weeks of treatment to complete additional questionnaires and cognitive assessments.
Phase 2 of the study is a double-blind clinical trial of this solution in patients with anxiety (n=40). 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 solution or placebo solution to self-administer throughout the six week treatment period, as described above. Participants will complete in-person visits and phone check-ins 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 six weeks of treatment to complete additional questionnaires, cognitive assessments, and an optional MRI scan. Note: Phase 2 was planned but study termination occurred prior to commencement.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- Mclean Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject has provided informed consent
- Subject is 18 or older
- Subject is a native English speaker or acquired English prior to age 5
- Subject endorses moderate or severe anxiety at the screening visit
Exclusion Criteria:
- Non-native English speakers
- Estimated IQ < 75
- Current substance abuse/dependence, psychotic disorder, bipolar disorder, or an eating disorder
- A history of head injury or loss of consciousness greater than 5 minutes
- Currently uses marijuana or cannabinoid-based products more frequently than 1x/month
- Female subjects will be excluded if they have a positive urine pregnancy test, or if they are currently breastfeeding
- Presence of a serious medical illness, including liver or kidney disease, or neurological disorder
- Allergy to coconut oil
- Current use of valproate
- Additional exclusions related to MR imaging, including claustrophobia, metal implanted within the body, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBD
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
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Participants will receive CBD solution during the open-label phase of the trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Time Frame: 6 weeks
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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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6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P003885
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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