A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
Primary Purpose
Anxiety
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBD
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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.
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBD
Arm Description
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
Outcomes
Primary Outcome Measures
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, and will be given to participants on a weekly basis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04286594
Brief Title
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
Official Title
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Terminated by sponsor
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 24, 2023 (Actual)
Study Completion Date
August 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This open-label to double-blind study evaluates the impact of cannabidiol (CBD) on anxiety in adults. Participants will use a custom-formulated sublingual (under-the-tongue) solution of whole plant, hemp-derived CBD twice daily for six weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. Quality of life, sleep, general health, and cognitive function will also be assessed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBD
Arm Type
Experimental
Arm Description
0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks.
Intervention Type
Drug
Intervention Name(s)
CBD
Intervention Description
Participants will receive CBD solution during the open-label phase of the trial.
Primary Outcome Measure Information:
Title
Change from Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
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