CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder (CR-GAD-60)

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.