Generalized Anxiety DisorderCR-GAD-60NCT07821840
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
A study testing Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm) in people with Generalized Anxiety Disorder, run by Associação Pan-Americana Multidisciplinar de Endocanabinologia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation of Cannariver CBD Calm in Adults With Generalized Anxiety Disorder: An Open-Label, Single-Group, Non-Randomized Interventional Study
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.
Read the detailed description
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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm)
- Keywords
- Cannabidiol, CBD, Cannabigerol, CBG, Cannabinol, CBN, Generalized Anxiety Disorder, GAD-7, Sleep Quality, Psychological Well-Being
- Medical subject headings
- Generalized Anxiety Disorder, Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| CannaRiver CBD Calm Tincture | Experimental | 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. Receives: Drug: Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8 (Day 56 ±5 days)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive the same CannaRiver CBD Calm intervention. There is no placebo or concurrent comparator group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Pan-Americana Multidisciplinar de Endocanabinologia
- Sponsor type
- University, hospital or other
- Collaborators
- Lidera Health Tecnologia LTDA., Canna River LLC DBA River Botanicals
- Responsible party
- Sponsor
- Investigators
- José Wilson N V Andrade, MD, Principal investigator, Associação Pan-Americana Multidisciplinar de Endocanabinologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821840
- Sponsor's protocol ID
- CR-INT-ANXIETY-60
- Acronym
- CR-GAD-60
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be made available upon reasonable request to the principal investigator after study completion and publication of primary results.
Publications
Des Jarlais DC, Lyles C, Crepaz N; TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004 Mar;94(3):361-6. doi: 10.2105/ajph.94.3.361.
PubMed 14998794Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Austin PC, White IR, Lee DS, van Buuren S. Missing Data in Clinical Research: A Tutorial on Multiple Imputation. Can J Cardiol. 2021 Sep;37(9):1322-1331. doi: 10.1016/j.cjca.2020.11.010. Epub 2020 Dec 1.
PubMed 33276049Pugh SL, Brown PD, Enserro D. Missing repeated measures data in clinical trials. Neurooncol Pract. 2021 Jul 16;9(1):35-42. doi: 10.1093/nop/npab043. eCollection 2022 Feb.
PubMed 35096402Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9.
PubMed 21145786de Souza CM, Hidalgo MP. World Health Organization 5-item well-being index: validation of the Brazilian Portuguese version. Eur Arch Psychiatry Clin Neurosci. 2012 Apr;262(3):239-44. doi: 10.1007/s00406-011-0255-x. Epub 2011 Sep 7.
PubMed 21912931Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Kahan BC, Hindley J, Edwards M, Cro S, Morris TP. The estimands framework: a primer on the ICH E9(R1) addendum. BMJ. 2024 Jan 23;384:e076316. doi: 10.1136/bmj-2023-076316.
PubMed 38262663Toussaint A, Husing P, Gumz A, Wingenfeld K, Harter M, Schramm E, Lowe B. Sensitivity to change and minimal clinically important difference of the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord. 2020 Mar 15;265:395-401. doi: 10.1016/j.jad.2020.01.032. Epub 2020 Jan 15.
PubMed 32090765Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Florian J, Salcedo P, Burkhart K, Shah A, Chekka LMS, Keshishi D, Patel V, Yang S, Fein M, DePalma R, Matta M, Strauss DG, Rouse R. Cannabidiol and Liver Enzyme Level Elevations in Healthy Adults: A Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1070-1078. doi: 10.1001/jamainternmed.2025.2366.
PubMed 40622698Lo LA, Christiansen A, Eadie L, Strickland JC, Kim DD, Boivin M, Barr AM, MacCallum CA. Cannabidiol-associated hepatotoxicity: A systematic review and meta-analysis. J Intern Med. 2023 Jun;293(6):724-752. doi: 10.1111/joim.13627. Epub 2023 Mar 13.
PubMed 36912195Morrison G, Crockett J, Blakey G, Sommerville K. A Phase 1, Open-Label, Pharmacokinetic Trial to Investigate Possible Drug-Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects. Clin Pharmacol Drug Dev. 2019 Nov;8(8):1009-1031. doi: 10.1002/cpdd.665. Epub 2019 Feb 21.
PubMed 30791225
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Cannariver CBD Calm in Adults With Generalized Anxiety Disorder: An Open-Label, Single-Group, Non-Randomized Interventional Study
- ClinicalTrials.gov ID
- NCT07821840
- Acronym / sponsor ID
- CR-GAD-60 / CR-INT-ANXIETY-60
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Cannabidiol, CBD, Cannabigerol, CBG, Cannabinol, CBN, Generalized Anxiety Disorder, GAD-7
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Associação Pan-Americana Multidisciplinar de EndocanabinologiaUniversity, hospital or other
- Collaborators
- Lidera Health Tecnologia LTDA., Canna River LLC DBA River Botanicals
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the same CannaRiver CBD Calm intervention. There is no placebo or concurrent comparator group.
| Arm | Type | Receives |
|---|---|---|
| CannaRiver CBD Calm Tincture | Experimental | Drug: Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | CannaRiver CBD Calm Tincture |
Primary outcome
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score From Baseline to Week 8
Time frame: Baseline to Week 8 (Day 56 ±5 days)
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.
6 secondary outcomes
Trajectory of GAD-7 Total Score From Baseline Through Week 12
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
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
Time frame: Baseline to Week 8 (Day 56 ±5 days)
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score From Baseline to Week 8
Time frame: Baseline to Week 8 (Day 56 ±5 days)
Adherence to the CannaRiver CBD Calm Dosing Schedule Through Week 8
Time frame: From first dose through Week 8 (Day 56)
Treatment-Emergent Adverse Events and Serious Adverse Events Through Week 12
Time frame: From first dose through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 14998794Des Jarlais DC, Lyles C, Crepaz N; TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004 Mar;94(3):361-6. doi: 10.2105/ajph.94.3.361.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 33276049Austin PC, White IR, Lee DS, van Buuren S. Missing Data in Clinical Research: A Tutorial on Multiple Imputation. Can J Cardiol. 2021 Sep;37(9):1322-1331. doi: 10.1016/j.cjca.2020.11.010. Epub 2020 Dec 1.
- Background: PubMed 35096402Pugh SL, Brown PD, Enserro D. Missing repeated measures data in clinical trials. Neurooncol Pract. 2021 Jul 16;9(1):35-42. doi: 10.1093/nop/npab043. eCollection 2022 Feb.
- Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
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- Individual participant dataSharing planned: Undecided. Individual participant data may be made available upon reasonable request to the principal investigator after study completion and publication of primary results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Wilson N V Andrade, MD principal investigator
Associação Pan-Americana Multidisciplinar de Endocanabinologia
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol (CBD) With Cannabinol (CBN) and Cannabigerol (CBG) Oral Tincture (CannaRiver CBD Calm) in people with Generalized Anxiety Disorder, run by Associação Pan-Americana Multidisciplinar de Endocanabinologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Wilson N V Andrade, MD (+55 11 971905328, dr.jwilsonandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score From Baseline to Week 8 (time frame: Baseline to Week 8 (Day 56 ±5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821840, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.