AnxietyPhase 2NCT02548559

Sublingual Cannabidiol for Anxiety

A Phase 2 study testing Full-Spectrum Cannabidiol and Single-Compound Cannabidiol in people with Anxiety, run by Staci Gruber, Ph.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety
What is being tested?: Full-Spectrum Cannabidiol and Single-Compound Cannabidiol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 14 Aug 2018to 13 Mar 2025
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

18 or older
Native English speaker or acquired English prior to age 5
Provides informed consent
Endorses moderate or severe anxiety at the screening visit

Who cannot join

Non-native English speakers
Estimated IQ < 75
Pregnancy
Presence of serious medical illness, including liver or kidney disease, neurological disorder, or certain psychiatric disorders
History of head injury or loss of consciousness >5 minutes
Current use of cannabis or cannabinoid products >1x/month

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital Brain Imaging Center
Belmont, Massachusetts, 02478-9106

Other trials in United States

About this study

This is an open-label to double-blind study evaluating the effects of cannabidiol (CBD) for the treatment of anxiety in adults. Participants will use a sublingual (under-the-tongue) solution of whole plant-derived CBD or placebo three times daily for four weeks in addition to their normal treatment regimen. Participants' clinical state will be assessed weekly during the treatment period. In addition, cognitive function and measures of quality of life, sleep, and general health will be assessed at baseline and the post-treatment final visit.

Read the detailed description

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 stages. Stage 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. Stage 1 of the study was completed in early 2020.

Stage 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 stage 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.

Conditions: Anxiety
Being tested: Full-Spectrum Cannabidiol, Single-Compound Cannabidiol, Placebo
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Full-Spectrum CannabidiolDrug
Full-Spectrum Cannabidiol; total daily dose of 30 mg.
Single-Compound CannabidiolDrug
Single-Compound Cannabidiol; total daily dose of 30 mg.
PlaceboDrug
Placebo solution.

Study groups in NCT02548559
Study group	Role	What they receive
Full-Spectrum Cannabidiol	Experimental	1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. Receives: Drug: Full-Spectrum Cannabidiol
Single-Compound Cannabidiol	Experimental	1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks. Receives: Drug: Single-Compound Cannabidiol
Placebo	Placebo comparator	1 ml of placebo solution administered three times per day (TID) for four weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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, with total scores ranging from 0 to 63 (higher scores indicating more anxiety).
Measured: 4 Weeks
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
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; total scores range from 0 to 20 (higher scores indicating more anxiety).
Measured: 4 Weeks
Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
This self-report measure is comprised of two 20-item scales (STAI-State and STAI-Trait), with a range of four possible responses from 1 to 4 (higher scores indicating more anxiety), and differentiates between the more temporary condition of "state" anxiety and the more general quality of "trait" anxiety. Total scores on each scale range from 20-80, with higher scores indicating more anxiety.
Measured: 4 Weeks
Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)
This observer-rated 14-item scale is administered in the form of an interview, and allows information from multiple sources to influence ratings (i.e. subject report, examiner's observation), and has been shown to be reliable index of clinical state. A range of 5 possible responses (0-4, not present-very severe) are possible for each item, with a total score range of 0-56 with higher scores indicating more anxiety.
Measured: 4 Weeks

Secondary outcomes (3)

Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
The BDI is a 21 item-self-report measure that can be used to assess the severity of depression. Each item on the BDI relates to a symptom of depression and is rated by the subject using a 0-3 scale (higher scores indicating increased severity), with a total score range of 0-63.
Measured: 4 Weeks
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI contains 19 self-rated questions that assess sleep quality and disturbance over the previous 1-month period. The 19 items yield seven component scores such as sleep latency, sleep duration, and daytime dysfunction, which are then summed to generate a global score ranging from 0-21 (higher scores indicating lower sleep quality).
Measured: 4 Weeks
Patient's Global Impression of Change (PGIC) Scale Score at Week 4
The PGIC is a single-question, 7-point scale depicting a patient's rating of overall improvement since baseline from "very much worse" (score=1) to "very much improved" (score=7). Higher scores indicate greater improvement.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201813 Mar 2025

First posted14 Sep 2015 (estimated)
Study start14 Aug 2018
Primary completion13 Mar 2025
Study completion13 Mar 2025

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548559
Sponsor's protocol ID: 2015P000959
Status last verified: Mar 2026
First submitted: 4 Sep 2015
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sublingual Cannabidiol for Anxiety
ClinicalTrials.gov ID: NCT02548559
Acronym / sponsor ID: 2015P000959
Conditions: Anxiety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Staci Gruber, Ph.D.University, hospital or other
Study start: 14 Aug 2018 (actual)
Primary completion: 13 Mar 2025 (actual)
Study completion: 13 Mar 2025 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Full-Spectrum Cannabidiol	Experimental	Drug: Full-Spectrum Cannabidiol1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Single-Compound Cannabidiol	Experimental	Drug: Single-Compound Cannabidiol1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
Placebo	Placebo comparator	Drug: Placebo1 ml of placebo solution administered three times per day (TID) for four 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)

18 or older
Native English speaker or acquired English prior to age 5
Provides informed consent
Endorses moderate or severe anxiety at the screening visit

Key exclusion criteria (6 listed)

Non-native English speakers
Estimated IQ < 75
Pregnancy
Presence of serious medical illness, including liver or kidney disease, neurological disorder, or certain psychiatric disorders
History of head injury or loss of consciousness >5 minutes

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
Full-Spectrum CannabidiolFull-Spectrum Cannabidiol; total daily dose of 30 mg.	Drug	Full-Spectrum Cannabidiol
Single-Compound CannabidiolSingle-Compound Cannabidiol; total daily dose of 30 mg.	Drug	Single-Compound Cannabidiol
PlaceboPlacebo solution.	Drug	Placebo

Primary outcome

Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Time frame: 4 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, with total scores ranging from 0 to 63 (higher scores indicating more anxiety).
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 4 Weeks
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; total scores range from 0 to 20 (higher scores indicating more anxiety).
Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: 4 Weeks
This self-report measure is comprised of two 20-item scales (STAI-State and STAI-Trait), with a range of four possible responses from 1 to 4 (higher scores indicating more anxiety), and differentiates between the more temporary condition of "state" anxiety and the more general quality of "trait" anxiety. Total scores on each scale range from 20-80, with higher scores indicating more anxiety.
Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)
Time frame: 4 Weeks
This observer-rated 14-item scale is administered in the form of an interview, and allows information from multiple sources to influence ratings (i.e. subject report, examiner's observation), and has been shown to be reliable index of clinical state. A range of 5 possible responses (0-4, not present-very severe) are possible for each item, with a total score range of 0-56 with higher scores indicating more anxiety.

3 secondary outcomes

Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Time frame: 4 Weeks
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 Weeks
Patient's Global Impression of Change (PGIC) Scale Score at Week 4
Time frame: Week 4

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full-Spectrum Cannabidiol	15	14
Single-Compound Cannabidiol	0	0
Placebo	0	0

Primary outcome: Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)

Time frame: 4 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Full-Spectrum Cannabidiol n = 32	Single-Compound Cannabidiol n = 6	Placebo n = 6
Baseline	20.97 (8.34)	22.50 (5.43)	21.00 (4.10)
Week 4	6.88 (5.80)	10.00 (5.90)	8.17 (4.96)

Full-Spectrum Cannabidiol: p <0.001, t-test, 1 sided
Single-Compound Cannabidiol: p = 0.006, t-test, 1 sided
Placebo: p = 0.002, t-test, 1 sided

Population analysed: Study completers were analyzed from both Stage 1 and Stage 2.

Primary outcome: Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)

Time frame: 4 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Full-Spectrum Cannabidiol n = 32	Single-Compound Cannabidiol n = 6	Placebo n = 6
Baseline	11.63 (2.08)	12.00 (2.53)	11.17 (2.04)
4 Weeks	5.00 (3.24)	7.50 (2.43)	5.50 (2.81)

Full-Spectrum Cannabidiol: p <0.001, t-test, 1 sided
Single-Compound Cannabidiol: p = 0.029, t-test, 1 sided
Placebo: p = 0.009, t-test, 1 sided

Population analysed: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).

Primary outcome: Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)

Time frame: 4 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Full-Spectrum Cannabidiol n = 32	Single-Compound Cannabidiol n = 6	Placebo n = 6
STAI-State Baseline	51.66 (10.27)	52.00 (8.27)	51.67 (12.96)
STAI-State Week 4	38.28 (11.30)	41.17 (5.98)	42.67 (6.86)
STAI-Trait Baseline	57.34 (8.70)	56.33 (4.18)	53.33 (7.89)
STAI-Trait Week 4	45.94 (9.81)	50.17 (4.45)	43.67 (10.15)

Full-Spectrum Cannabidiol: p <0.001, t-test, 1 sided
Single-Compound Cannabidiol: p = 0.025, t-test, 1 sided
Placebo: p = 0.026, t-test, 1 sided

Population analysed: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).

Primary outcome: Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)

Time frame: 4 Weeks. Mean (Standard Deviation). Unit: Score

Measure	Full-Spectrum Cannabidiol n = 32	Single-Compound Cannabidiol n = 6	Placebo n = 6
Baseline	21.47 (5.49)	23.67 (5.47)	20.17 (4.92)
Week 4	5.13 (3.50)	9.67 (6.56)	17.50 (6.09)

Full-Spectrum Cannabidiol: p <0.001, t-test, 1 sided
Single-Compound Cannabidiol: p = 0.001, t-test, 1 sided
Placebo: p = 0.134, t-test, 1 sided

Population analysed: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 4 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full-Spectrum Cannabidiol	0 of 34 (0%)	8 of 34 (23.5%)	0 of 34
Single-Compound Cannabidiol	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Placebo	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Staci Gruber, PhD. principal investigator

Mclean Hospital

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 Full-Spectrum Cannabidiol and Single-Compound Cannabidiol in people with Anxiety, run by Staci Gruber, Ph.D. 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 6 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: finished, as of the sponsor's last update on 27 Mar 2026. 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. Some participants in this study may receive a placebo. 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 Mar 2026). 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?

Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) (time frame: 4 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548559.

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 Mar 2026.