An interventional study of Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm) in Generalized Anxiety Disorder, sponsored by Associação Pan-Americana Multidisciplinar de Endocanabinologia. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Associação Pan-Americana Multidisciplinar de Endocanabinologia · Not applicable, Interventional, and Treatment
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.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 60 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Associação Pan-Americana Multidisciplinar de Endocanabinologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive CannaRiver CBD Calm, an oral/sublingual broad-spectrum cannabinoid tincture containing cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG), at 0.5 mL approximately every 12 hours for 8 weeks. There is no placebo or concurrent comparator group. The intervention is not routinely titrated. The actual cannabinoid exposure will be based on the lot-specific Certificate of Analysis.
Drug: Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm)
CannaRiver 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.
Time frame: Baseline to Week 8 (Day 56 ±5 days)
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.
Time frame: Baseline, Weeks 2, 4, 6, 8, and 12
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.
Time frame: Baseline to Week 8 (Day 56 ±5 days)
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.
Time frame: Baseline to Week 8 (Day 56 ±5 days)
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.
Time frame: Baseline to Week 8 (Day 56 ±5 days)
Adherence to the CannaRiver CBD Calm Dosing Schedule Through Week 8
Adherence will be assessed using electronic dose diaries, participant reports, returned-product reconciliation, and documented dose interruptions. The percentage of expected doses taken during the applicable exposure period will be summarized.
Time frame: From first dose through Week 8 (Day 56)
Treatment-Emergent Adverse Events and Serious Adverse Events Through Week 12
Treatment-emergent adverse events, serious adverse events, events leading to product interruption or discontinuation, clinically suspected liver injury, serum AST and ALT values at baseline/Day 0, Week 4 and Week 8/end of treatment, sedation or psychomotor symptoms, gastrointestinal symptoms, psychiatric deterioration, suicidality, pregnancy, and suspected medication interactions will be collected and summarized. Routine urine, toxicology and pregnancy testing is not planned; additional testing will be clinically indicated when needed.
Time frame: From first dose through Week 12
No study locations are listed for this record.
Plan to share: Undecided — Individual participant data may be made available upon reasonable request to the principal investigator after study completion and publication of primary results.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's planned 4 months is below that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
Associação Pan-Americana Multidisciplinar de Endocanabinologia