Hemp-Derived CBD Sublingual Solution Reduced Anxiety in Small Open-Label Pilot

In a 6-week open-label trial of 12 patients, a hemp-derived CBD sublingual solution at 30 mg/day significantly reduced anxiety while improving mood, sleep, and cognitive performance.

Smith, Rosemary T et al.·Biomedicines·2025·Preliminary Evidenceclinical-trial
RTHC-07684Clinical TrialPreliminary Evidence2025RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
clinical-trial
Evidence
Preliminary Evidence
Sample
N=12

What This Study Found

Patients reported significant reductions in anxiety symptoms over 6 weeks. Concurrent improvements in mood, sleep, and quality of life were observed, along with stable or improved performance on executive function and memory tests. Few side effects and no serious adverse events occurred.

Key Numbers

12 patients with moderate-to-severe anxiety. 30 mg/day CBD for 6 weeks. Significant anxiety reduction. Improved mood, sleep, quality of life. Stable or improved cognition. No serious adverse events.

How They Did This

Open-label pilot trial (NCT04286594) of 12 patients with at least moderate anxiety. Participants self-administered a hemp-derived, full-spectrum, high-CBD sublingual solution twice daily (target: 30 mg/day CBD) for 6 weeks. Assessments included anxiety, mood, sleep, quality of life, and neurocognitive measures.

Why This Research Matters

While many commercial CBD products claim anxiety benefits, few have been tested in even basic clinical trials. This pilot provides initial clinical data on a product similar to what is commercially available.

The Bigger Picture

This is a pilot without a placebo control, so the improvements could reflect placebo effects, natural symptom fluctuation, or expectation bias. Placebo-controlled trials are needed before drawing conclusions about efficacy.

What This Study Doesn't Tell Us

No placebo control or blinding. Only 12 participants. 6-week duration only. Full-spectrum product contains trace THC (<=0.3%), so effects cannot be attributed to CBD alone. Industry-relevant product tested in a very small sample.

Questions This Raises

  • ?Would a placebo-controlled trial replicate these findings?
  • ?How much of the effect is due to CBD specifically versus the full-spectrum formulation?

Trust & Context

Key Stat:
Evidence Grade:
Open-label design with no placebo control and only 12 participants places this firmly at preliminary evidence.
Study Age:
Recently published pilot trial (NCT04286594).
Original Title:
Clinical and Cognitive Improvement Following Treatment with a Hemp-Derived, Full-Spectrum, High-Cannabidiol Product in Patients with Anxiety: An Open-Label Pilot Study.
Published In:
Biomedicines, 13(8) (2025)
Database ID:
RTHC-07684

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-Control
Cross-Sectional / ObservationalSnapshot without intervening
This study
Case Report / Animal Study
What do these levels mean? →

Frequently Asked Questions

Does this prove CBD works for anxiety?

No. This open-label pilot with 12 patients and no placebo control cannot prove efficacy. It provides initial signals that warrant larger, controlled studies.

Is this the same CBD you can buy in stores?

The product was a hemp-derived, full-spectrum sublingual solution similar to commercially available products, making the results potentially more relevant to real-world use than pharmaceutical-grade CBD studies.

Read More on RethinkTHC

Cite This Study

RTHC-07684·https://rethinkthc.com/research/RTHC-07684

APA

Smith, Rosemary T; Dahlgren, Mary Kathryn; Sagar, Kelly A; Kosereisoglu, Deniz; Gruber, Staci A. (2025). Clinical and Cognitive Improvement Following Treatment with a Hemp-Derived, Full-Spectrum, High-Cannabidiol Product in Patients with Anxiety: An Open-Label Pilot Study.. Biomedicines, 13(8). https://doi.org/10.3390/biomedicines13081874

MLA

Smith, Rosemary T, et al. "Clinical and Cognitive Improvement Following Treatment with a Hemp-Derived, Full-Spectrum, High-Cannabidiol Product in Patients with Anxiety: An Open-Label Pilot Study.." Biomedicines, 2025. https://doi.org/10.3390/biomedicines13081874

RethinkTHC

RethinkTHC Research Database. "Clinical and Cognitive Improvement Following Treatment with ..." RTHC-07684. Retrieved from https://rethinkthc.com/research/smith-2025-clinical-and-cognitive-improvement

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.