AnxietyPhase 2NCT04286594
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
A Phase 2 study testing CBD in people with Anxiety, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- CBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 24 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- CBD
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
Participants will receive CBD solution during the open-label phase of the trial.
| Study group | Role | What they receive |
|---|---|---|
| CBD | Experimental | 0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks. Receives: Drug: CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The possible range of scores is 0-63.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Feb 2021
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Why it stopped: Terminated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staci Gruber, Ph.D., Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286594
- Sponsor's protocol ID
- 2019P003885
- Status last verified
- Aug 2024
- First submitted
- 25 Feb 2020
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
- ClinicalTrials.gov ID
- NCT04286594
- Acronym / sponsor ID
- 2019P003885
- Conditions
- Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by sponsor
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Posted 27 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBD | Experimental | Drug: CBD0.5ml of sublingual CBD solution (30mg/ml) administered twice daily for six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBDParticipants will receive CBD solution during the open-label phase of the trial. | Drug | CBD |
Primary outcome
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Time frame: 6 weeks
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. The possible range of scores is 0-63.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD in people with Anxiety, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.