CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder

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.

Inclusion Criteria: * 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. * GAD-7 total score of at least 10 at screening and again at baseline, within the prespecified interval. * Stable permitted psychiatric medication regimen for at least 6 weeks before baseline, if applicable, with no elective dose change planned during the 8-week treatment period. * Stable psychotherapy modality and frequency for at least 8 weeks before baseline, if applicable, with no elective intensification planned during treatment. * Willingness to administer the study product at 0.5 mL approximately every 12 hours for 8 weeks, complete electronic assessments, attend scheduled contacts, return unused product, and report medications, supplements, alcohol, cannabis, and adverse events. * Access to a compatible smartphone or web-enabled device and sufficient Portuguese literacy for the approved participant-reported instruments. * For participants with reproductive potential, no known or suspected pregnancy, agreement to the approved contraception requirements, and no plan for pregnancy through the end of the safety follow-up. Exclusion Criteria: * 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. * Pregnancy, breastfeeding, attempting to become pregnant, intention to become pregnant during the study, or refusal to comply with pregnancy-prevention requirements. * Active liver disease; clinically important previous drug-induced liver injury; known clinically significant hepatic dysfunction; current jaundice, dark urine, pale stools, persistent unexplained right-upper-quadrant pain, or another finding judged by the investigator to create unacceptable hepatic risk. * Clinically significant renal, cardiovascular, neurologic, respiratory, endocrine, or gastrointestinal disease that may increase risk or confound outcomes. * Severe untreated obstructive sleep apnea, severe uncontrolled daytime sleepiness, recurrent unexplained syncope, or an occupation that cannot accommodate temporary driving or safety-sensitive-work restrictions. * Known hypersensitivity to cannabinoids, MCT oil, or a confirmed product component. * Current clobazam, valproate, or stiripentol use. Other sedatives, opioids, sedating antihistamines, muscle relaxants, sedating antipsychotics, strong CYP3A4/CYP2C19 modulators, narrow-therapeutic-index medicines, or selected antiepileptic medicines require protocol-approved investigator and pharmacist review. * Unstable medication or psychotherapy regimen, planned elective medication change during treatment, or another interventional study within 30 days or five half-lives, whichever is longer. * Inability to comply with study visits, electronic assessments, clinical safety monitoring, product accountability, or emergency procedures. * Any other condition judged by the investigator to be incompatible with safe participation or scientifically interpretable follow-up.