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

Generalized anxiety disorder is a chronic condition characterized by excessive and difficult-to-control worry and associated symptoms that may include restlessness, fatigue, impaired concentration, irritability, muscle tension, and sleep disturbance. Evidence for cannabidiol in anxiety is heterogeneous and formulation-specific. Acute experimental studies involving CBD, including studies associated with the Crippa and Zuardi research programs, provide a rationale for further investigation but do not establish efficacy for generalized anxiety disorder or for the CannaRiver formulation. Evidence for the combined use of CBD, CBN, and CBG in this formulation and schedule is limited. The study will enroll approximately 60 adults with clinician-confirmed generalized anxiety disorder and a GAD-7 score of at least 10 at screening and baseline, subject to the final ethics-approved age range. Participants will receive CannaRiver CBD Calm at 0.5 mL approximately every 12 hours for 8 weeks, followed by assessment through Week 12. The nominal product composition is 5,000 mg CBD, 1,250 mg CBN, and 1,250 mg CBG per 60 mL bottle; actual exposure will be based on the lot-specific Certificate of Analysis. The product will not be titrated routinely. The study is open-label, non-randomized, and single-group. It has no placebo or concurrent control group. The primary outcome is change in GAD-7 total score from baseline to Week 8. Secondary outcomes include trajectories of anxiety symptoms, selected measures of sleep quality and psychological well-being, adherence, retention, and safety. Optional instruments will be included only if their final versions, permissions, language validation, and electronic implementation are confirmed before registration. Scheduled serum AST/TGO and ALT/TGP testing will be performed at baseline/Day 0 before first dose, Week 4 and Week 8/end of treatment. These tests provide transaminase surveillance but are not a complete hepatic panel. Routine urine, toxicology and pregnancy testing is not planned. If results or symptoms suggest liver injury, or if another serious adverse event or urgent condition occurs, the study product will be interrupted when appropriate and the participant will be referred for clinical evaluation and additional diagnostic testing. The protocol remains limited by the possibility of changes between scheduled sampling time points. Data will be collected through the Lidera Health ePRO/eCRF environment, subject to documented validation, role-based access, audit trails, data-processing agreements, privacy-impact assessment, contingency procedures, and human review of safety alerts. The platform will not independently diagnose, determine eligibility, change the dose, assign causality, or replace clinical judgment or emergency services. The protocol will be submitted to the Research Ethics Committee (CEP) via Plataforma Brasil, following CNS Resolutions 466⁄2012 and 510⁄2016. Results will be reportedfollowing STROBE guidelines for observational studies.