Phase 2
N=15
Sublingual Cannabidiol for Anxiety
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02548559 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) — 20.97; 22.50; 21.00; 6.88 Score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Full-Spectrum Cannabidiol (Drug); Single-Compound Cannabidiol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Staci Gruber, Ph.D.
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Self-Reported Anxiety as Assessed by the Beck Anxiety Inventory (BAI) |
20.97; 22.50; 21.00; 6.88; 10.00; 8.17 | <0.001 sig |
| PRIMARY Change From Baseline in Anxiety Assessed by the Overall Anxiety Severity and Impairment Scale (OASIS) |
11.63; 12.00; 11.17; 5.00; 7.50; 5.50 | <0.001 sig |
| PRIMARY Change From Baseline in Self-Reported Anxiety Assessed by the State-Trait Anxiety Inventory (STAI) |
51.66; 52.00; 51.67; 38.28; 41.17; 42.67 | <0.001 sig |
| PRIMARY Change From Baseline in Anxiety Measured by the Hamilton Anxiety Scale (HAM-A) |
21.47; 23.67; 20.17; 5.13; 9.67; 17.50 | <0.001 sig |
| SECONDARY Change From Baseline in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI) |
21.13; 22.00; 17.50; 7.50; 6.83; 5.83 | <0.001 sig |
| SECONDARY Change From Baseline in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) |
8.97; 7.00; 8.33; 5.84; 4.33; 7.17 | <0.001 sig |
| SECONDARY Patient's Global Impression of Change (PGIC) Scale Score at Week 4 |
5.50; 4.00; 4.50 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Non-native English speakers
- Estimated IQ 5 minutes
- Current use of cannabis or cannabinoid products >1x/month
Data sourced from ClinicalTrials.gov (NCT02548559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.