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Phase 2 Completed N=15 Randomized Triple-blind Treatment

Sublingual Cannabidiol for Anxiety

Source: ClinicalTrials.gov NCT02548559 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: 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

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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