Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04286594 |
| Other study ID # |
2019P003885 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
August 24, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Mclean Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
