This open-label, single-group, non-randomized interventional study will evaluate longitudinal changes in anxiety symptoms, sleep quality, psychological well-being, treatment adherence, tolerability, and safety in adults with clinician-confirmed generalized anxiety disorder. Participants will receive CannaRiver CBD Calm, an oral/sublingual broad-spectrum cannabinoid tincture containing cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG), at a protocol dose of 0.5 mL approximately every 12 hours for 8 weeks. Follow-up will continue through Week 12. The study has no placebo or concurrent comparator group. The primary outcome is change in the Generalized Anxiety Disorder 7-item scale (GAD-7) total score from baseline to Week 8. Findings will be descriptive and hypothesis-generating; the design cannot establish that any observed change was caused by the product.
Adult within the final protocol-approved age range of 18-65 years years at the time of informed consent.
Capacity to understand the study and provide written informed consent before research procedures.
Clinician-confirmed generalized anxiety disorder using the prespecified structured diagnostic interview or another approved validated diagnostic method.
Clinically significant generalized anxiety disorder symptoms for at least 6 months.
Current psychotic disorder, bipolar I disorder, current mania or hypomania, severe and unstable major depressive episode, severe dissociation, or another psychiatric condition that compromises safety or interpretability.
Current suicidal intent or plan, preparatory behavior, recent suicide attempt within the protocol-defined interval, inability to collaborate with a safety plan, or investigator judgment that outpatient participation is unsafe.
Moderate or severe substance use disorder within the previous 12 months, other than nicotine or caffeine, or current recreational drug use likely to affect safety or outcomes.
Use of CBD, CBN, CBG, THC, cannabis-derived products, or another systemically absorbed cannabinoid product within 30 days before baseline, or inability to abstain through Week 12.
Single group
Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm)
DrugCannaRiver CBD Calm Tincture, broad-spectrum oral/sublingual cannabinoid formulation. The current nominal label states 5,000 mg CBD, 1,250 mg CBN, and 1,250 mg CBG per 60 mL bottle. At the protocol dose of 0.5 mL approximately every 12 hours, the nominal daily exposure is approximately 83.33 mg CBD, 20.83 mg CBN, and 20.83 mg CBG. The final record will use the lot-specific Certificate of Analysis and final product manual to describe the exact formulation, excipients, flavor, storage, dosing device, and validated administration instructions.
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score From Baseline to Week 8
The GAD-7 is a 7-item participant-reported measure scored from 0 to 21, with higher scores indicating greater anxiety symptom severity. Change will be calculated as the Week 8 score minus the baseline score. The primary analysis will estimate the mean within-participant change with a two-sided 95% confidence interval using the prespecified repeated-measures model.
Trajectory of GAD-7 Total Score From Baseline Through Week 12
GAD-7 total scores will be collected at baseline and scheduled follow-up visits to describe the longitudinal pattern of anxiety symptoms during treatment and after treatment. The study is uncontrolled; the trajectory will be interpreted as an observed within-participant pattern rather than a causal treatment effect.
Participants With a Decrease of at Least 4 Points in GAD-7 Total Score at Week 8
The number and percentage of participants with a decrease of at least 4 points from baseline to Week 8 will be summarized. The threshold is a prespecified descriptive benchmark and does not establish that the intervention caused the change.
Change in World Health Organization 5-Item Well-Being Index (WHO-5) Score From Baseline to Week
The WHO-5 is a participant-reported measure of positive psychological well-being. Scores will be transformed according to the prespecified scoring method, with higher scores indicating greater well-being. The analysis will estimate within-participant change from baseline to Week 8.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to Week 8
The PSQI global score is a participant-reported measure of global sleep quality over the preceding month. Change from baseline to Week 8 will be summarized using the prespecified analysis. Higher PSQI global scores indicate poorer sleep quality.
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Associação Pan-Americana Multidisciplinar de Endocanabinologia
Lead sponsor
Lidera Health Tecnologia LTDA.
Collaborator
Canna River LLC DBA River Botanicals
Collaborator
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