Trial Outcomes & Findings for Sublingual Cannabidiol for Anxiety (NCT NCT02548559)
NCT ID: NCT02548559
Last Updated: 2026-03-27
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
4 Weeks
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
Full-Spectrum Cannabidiol
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Placebo
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Stage 1: Open-Label
STARTED
|
15
|
0
|
0
|
|
Stage 1: Open-Label
COMPLETED
|
14
|
0
|
0
|
|
Stage 1: Open-Label
NOT COMPLETED
|
1
|
0
|
0
|
|
Stage 2: Double-Blind
STARTED
|
19
|
6
|
6
|
|
Stage 2: Double-Blind
COMPLETED
|
18
|
6
|
6
|
|
Stage 2: Double-Blind
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Full-Spectrum Cannabidiol
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Placebo
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Stage 1: Open-Label
Patient was disqualified due to use of other cannabinoid products at Visit 3, which was prohibited.
|
1
|
0
|
0
|
|
Stage 2: Double-Blind
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Sublingual Cannabidiol for Anxiety
Baseline characteristics by cohort
| Measure |
Total
n=46 Participants
Total of all reporting groups
|
Full-Spectrum Cannabidiol
n=34 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
|---|---|---|---|---|
|
Age, Continuous
|
31.87 Years
STANDARD_DEVIATION 12.00 • n=53 Participants
|
35.29 Years
STANDARD_DEVIATION 15.70 • n=56 Participants
|
30.83 Years
STANDARD_DEVIATION 7.00 • n=62 Participants
|
33.83 Years
STANDARD_DEVIATION 10.94 • n=123 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=53 Participants
|
24 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=53 Participants
|
10 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=53 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=53 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=53 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=53 Participants
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=53 Participants
|
29 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=53 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=53 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=53 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=53 Participants
|
33 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=53 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Years of Education
|
16.03 Years
STANDARD_DEVIATION 2.12 • n=53 Participants
|
15.97 Years
STANDARD_DEVIATION 2.01 • n=56 Participants
|
14.67 Years
STANDARD_DEVIATION 1.51 • n=62 Participants
|
17.67 Years
STANDARD_DEVIATION 1.97 • n=123 Participants
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Study completers were analyzed from both Stage 1 and Stage 2.
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).
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Baseline
|
21.00 Score
Standard Deviation 4.10
|
20.97 Score
Standard Deviation 8.34
|
22.50 Score
Standard Deviation 5.43
|
|
Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI)
Week 4
|
8.17 Score
Standard Deviation 4.96
|
6.88 Score
Standard Deviation 5.80
|
10.00 Score
Standard Deviation 5.90
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).
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).
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
Baseline
|
11.17 Score
Standard Deviation 2.04
|
11.63 Score
Standard Deviation 2.08
|
12.00 Score
Standard Deviation 2.53
|
|
Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)
4 Weeks
|
5.50 Score
Standard Deviation 2.81
|
5.00 Score
Standard Deviation 3.24
|
7.50 Score
Standard Deviation 2.43
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
STAI-State Baseline
|
51.67 Score
Standard Deviation 12.96
|
51.66 Score
Standard Deviation 10.27
|
52.00 Score
Standard Deviation 8.27
|
|
Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
STAI-State Week 4
|
42.67 Score
Standard Deviation 6.86
|
38.28 Score
Standard Deviation 11.30
|
41.17 Score
Standard Deviation 5.98
|
|
Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
STAI-Trait Baseline
|
53.33 Score
Standard Deviation 7.89
|
57.34 Score
Standard Deviation 8.70
|
56.33 Score
Standard Deviation 4.18
|
|
Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI)
STAI-Trait Week 4
|
43.67 Score
Standard Deviation 10.15
|
45.94 Score
Standard Deviation 9.81
|
50.17 Score
Standard Deviation 4.45
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)
Baseline
|
20.17 Score
Standard Deviation 4.92
|
21.47 Score
Standard Deviation 5.49
|
23.67 Score
Standard Deviation 5.47
|
|
Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A)
Week 4
|
17.50 Score
Standard Deviation 6.09
|
5.13 Score
Standard Deviation 3.50
|
9.67 Score
Standard Deviation 6.56
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Participants who completed the trial were included in analyses (Stage 1 and Stage 2)
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Baseline
|
17.50 Score
Standard Deviation 10.84
|
21.13 Score
Standard Deviation 10.43
|
22.00 Score
Standard Deviation 5.06
|
|
Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Week 4
|
5.83 Score
Standard Deviation 6.18
|
7.50 Score
Standard Deviation 7.51
|
6.83 Score
Standard Deviation 6.65
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).
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).
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
8.33 Score
Standard Deviation 3.01
|
8.97 Score
Standard Deviation 3.33
|
7.00 Score
Standard Deviation 2.19
|
|
Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Week 4
|
7.17 Score
Standard Deviation 3.25
|
5.84 Score
Standard Deviation 2.82
|
4.33 Score
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Week 4Population: Participants who completed the trial were included in analyses (Stage 1 and Stage 2).
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
Full-Spectrum Cannabidiol
n=32 Participants
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 Participants
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Patient's Global Impression of Change (PGIC) Scale Score at Week 4
|
4.50 Score
Inter-Quartile Range 1.47 • Interval 3.25 to 5.0
|
5.50 Score
Inter-Quartile Range 1.35 • Interval 4.75 to 6.0
|
4.00 Score
Inter-Quartile Range 2.23 • Interval 3.0 to 5.75
|
Adverse Events
Full-Spectrum Cannabidiol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Single-Compound Cannabidiol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Full-Spectrum Cannabidiol
n=34 participants at risk
1 ml of full-spectrum sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Single-Compound Cannabidiol
n=6 participants at risk
1 ml of single-compound sublingual cannabidiol solution (10 mg/ml CBD) administered three times per day (TID) for four weeks.
|
Placebo
n=6 participants at risk
1 ml of placebo solution administered three times per day (TID) for four weeks.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Insertion site pain at site of blood draw
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
General disorders
Dry mouth/throat discomfort
|
5.9%
2/34 • From enrollment until end of follow-up, up to 4 weeks.
|
16.7%
1/6 • From enrollment until end of follow-up, up to 4 weeks.
|
16.7%
1/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Gastrointestinal disorders
Stomachache
|
5.9%
2/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
General disorders
Lassitude
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Psychiatric disorders
Panic attack symptoms
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
General disorders
Feeling faint after blood draw
|
0.00%
0/34 • From enrollment until end of follow-up, up to 4 weeks.
|
16.7%
1/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Psychiatric disorders
Feeling "heady"
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
|
Psychiatric disorders
Derealization
|
2.9%
1/34 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
0.00%
0/6 • From enrollment until end of follow-up, up to 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place