AnxietyPhase 2NCT06672666
Use of CBD in the Treatment of Anxiety
A Phase 2 study testing Hemp Derived Cannabidiol Extract in people with Anxiety and Generalized Anxiety Disorder, run by University of Florida at 1 site in United States.
Trial summary
This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anxiety, Generalized Anxiety Disorder, Sleep Problems
- What is being tested?
- Hemp Derived Cannabidiol Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 31 Dec 2026
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Any biological sex and ages 18 to 55 years old
- Willing and able to give informed consent for participation in the study
- Willing and able to comply with all study requirements, including willingness to donate blood during the study
- Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A)
- Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation.
- Normal clinical history and laboratory test
Who cannot join
- Pregnancy or breastfeeding
- Any history of suicidal behavior or any suicidal ideation in the past six months or at screening
- Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of baseline visit.
- Active daily or almost daily (3+ days/week) use of cannabinoids or THC in the past month or any other illicit drug within the past 6 months
- Inability to refrain from using alcohol (4 or more drinks in one occasion or 3+ days/week), antiepileptics, antipsychotics, oral antifungals, verapamil, nitrofurantoin, or any other medication in drug classes, such as antibiotics, nonsteroidal anti-inflammatory drugs, herbal and dietary supplements, cardiovascular drugs, central nervous system agents, or antineoplastic drugs, inducing transaminase elevation based on the LiverTox database. 17,18
- Inability to adjust the doses of prescription medications displaying a narrow therapeutic index that are potentially impacted by concomitant cannabinoid use18,19.
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- Inability to refrain from using acetaminophen, or topic antifungals on a regular basis (more than two times per week) over the course of the trial.
- Active use of benzodiazepines, opioids, and antihistamines or any other medication inducing lethargy and sedation, except for antidepressants, for which detailed information will be collected.
- History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries at baseline (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) >2 times ULN (or the baseline value if baseline is elevated); Total serum bilirubin >2.5 mg/dL with elevated AST, ALT or ALP; or International normalized ratio (INR) >1.5 with elevated AST, ALT or ALP).20
- Current substance use disorder
- Unstable medical or neurological condition
- Positive drug screen for substances of abuse
- Lifetime history of psychotic disorder, bipolar disorder, PTSD or OCD
- Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate.
- Severe depression symptoms in the past six months.
- Known or suspected hypersensitivity to cannabidiol or any other components in the extract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Double-Blind Placebo-Controlled, Randomized, Safety, Efficacy, and Acceptability Trial of a Hemp-Derived Cannabidiol Extract for the Treatment of Anxiety
This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.
Read the detailed description
Approximately one-third (33.1%) of Americans will experience an anxiety disorder at some point in their lifetime. Anxiety disorders are primarily treated with antidepressants or benzodiazepines, but unfortunately, many patients report a partial response or cannot tolerate the side effects of these medications, which include risk for abuse, cognitive impairment, and even death. The therapeutic potential of various compounds derived from the Cannabis sativa plant has generated considerable interest, particularly for managing neuropsychiatric disorders that have limited treatment options. Among these compounds, tetrahydrocannabinol (THC) and cannabidiol (CBD), have received significant attention. CBD has shown a unique pharmacological profile that lacks the potential for abuse associated with THC. Animal and small-scale human studies have demonstrated CBD's anxiolytic, antidepressant, panicolytic, and anticompulsive actions, however more research is needed to investigate the mechanisms of action and determine whether these products represent a safe and effective option for the treatment of anxiety. This study will examine the safety and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires, blood, and urine exams will be used to comprehensively monitor adverse drug events. Clinical measurements will be performed to assess changes in anxiety and sleep quality. This study will also examine whether changes in sleep disturbances precede changes in anxiety symptoms. Participants will complete a comprehensive evaluation for the assessment of relevant medical history, and concomitant medication use. This study will provide information about the dosing and safety profile of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract among individuals with anxiety. In addition, the study will provide preliminary evidence of the independent and concomitant effects of CBD on anxiety symptoms and sleep patterns among individuals with anxiety and finally will assess the feasibility and acceptability of study procedures, including dosing, adherence to the study protocols, and the assessment of anxiety symptoms and sleep disturbances measurements over time.
- Conditions
- Anxiety, Generalized Anxiety Disorder, Sleep Problems
- Being tested
- Hemp Derived Cannabidiol Extract, Placebo
- Keywords
- Anxiety, CBD, Cannabidiol, Hemp-Derived Cannabidiol Extract, Generalized Anxiety Disorder, GAD, sleep
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp Derived Cannabidiol ExtractDrug
Also called SunFlora CBD Extract
Participants will be given the study drug in a titrated method of 50-150mgs per day for 4 weeks
PlaceboDrug
Partcipants will be given placebo substance to be taken with titrated instructions that mimic IP dispensing method daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hemp Derived Cannabidiol Extract | Experimental | SunFlora's CBD Extract 50mg to 150mg titrated over 4 weeks Receives: Drug: Hemp Derived Cannabidiol Extract |
| Placebo | Placebo comparator | Placebo substance to reflect same consistency as the experimental drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average CBD dose (mgs) used in the titration phase as reported in participant forms.
This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (from 50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the titration phase, participants will be instructed to use an initial dosing of 50 mg/day in the morning progressively increasing 50 mg CBD/day before bedtime as tolerated by the individual participant, up to 150 mg/day by day 14. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.
Measured: From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).
Average CBD dose (mgs) used in the maintenance phase as indicated and reported in participant forms.
This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the maintenance phase, participants will stay at the optimal tolerated dose (between 50-150 mg) for two additional weeks. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.
Measured: From week 2 to the end of maintenance phase at 4 weeks (Day 15 to Day 28)
Percentage of Severity of treatment-related adverse events based on the side effects/adverse events checklist, laboratory test, and self-report of unexpected ADE
The safety and tolerability will be determined in eight-assessments conducted during a 12-week period, and based on the side effects/adverse events checklist, laboratory tests, and self-reports of unexpected adverse drug events (ADEs). The type of treatment-related adverse events based will be characterized based on those assessments. The side effects/adverse events will be categorized as: no ADEs, mild (i.e., no intervention required; no impact on activities of daily living), moderate (minimal, local, or non-invasive intervention indicated; moderate impact on activities of daily living) or severe (i.e., significant symptoms requiring invasive intervention; subject seeks medical attention, needs major assistance).
Measured: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84)
Percentage of patients reporting Drug-Induced Liver Injury based on liver chemistries
In this study, patients are going to be followed for 84 days after treatment initiation, with serum liver chemistries assessments at baseline, and in four subsequent visits (visits 3, 5, 6 and 8), with the last serum liver chemistries 49 days after the last doses. The result is reported as the number of participants that had a clinically significant clinically significant elevation in serum liver chemistries (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) >2 times ULN, Total serum bilirubin >2.5 mg/dL with elevated AST, ALT or ALP; or International normalized ratio (INR) >1.5 with elevated AST, ALT or ALP.
Measured: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Percentage of severity of depression symptoms based on the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a 9-item scale useful for the assessment of the presence and severity of depressive symptom, and a possible depressive disorder. Each of the nine items reflects a DSM-5 symptom of depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Percentage of participants reporting suicidal ideation and behavior based on the Columbia Suicide Severity Rating Scale
The Columbia Suicide Severity Rating Scale (C-SSRS) is a 6-item scale that assesses suicidal ideation and behavior by helping to identify specific behaviors that may be indicative of an individual's intent to kill oneself. Four constructs are measured, including: severity of ideation, intensity of ideation, behavior and lethality.
Measured: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Secondary outcomes (7)
Change in anxiety symptoms scores based on the Hamilton Anxiety Rating Scale.
This study will provide preliminary evidence of the independent and concomitant effects of CBD on anxiety symptoms among individuals with moderate to severe anxiety. Anxiety symptoms will be assessed over the 12-week period using the Hamilton Anxiety Rating Scale (HAM-A). This scale consists of 14 symptom-defined elements, and caters for both psychological (e.g., fears, anhedonia) and somatic (e.g., tachycardia, chest tightness) symptoms. Each item is scored on a basic numeric scoring of 0 (not present) to 4 (severe). HAM-A score ranges are: mild anxiety = 8-14; moderate = 15-23; severe 24 or more. Scores below 8 were considered to represent no/minimal anxiety. For this study the HAM-A test will be conducted during eight assessments in the 12-week study period.
Measured: From enrollment to the end of treatment at 4 weeks
Change in perceived severity of anxiety symptoms and functionality based on the Clinical Global Impression.
This study will assess the change in perceived severity of anxiety symptoms and functionality based on the Clinical Global Impression (CGI). The CGI is a 3-item scale that assesses the patient's functioning prior to and after initiating medication in trials which is an important part of the study process. Its 3 items assess, 1) Severity of Illness (CGI-S), 2) Global Improvement (CGI-I), and 3) Efficacy Index (CGI-E, which is a measure of treatment effect and side effects specific to drugs that were administered). For this study the CGI test will be conducted during eight assessments in the 12-week study period.
Measured: From enrollment to the end of treatment at 4 weeks
Change in generalized anxiety symptoms and severity based on the Generalized Anxiety Disorder 7 scale
This study will provide preliminary evidence of the independent and concomitant effects of CBD on generalized anxiety symptoms among individuals with moderate to severe anxiety using the Generalized Anxiety Disorder 7 (GAD 7). This 7-items scale with strong criterion validity is useful for identifying probable cases of GAD and assessing its severity. Increasing scores on the GAD-7 are strongly associated with multiple domains o symptoms will be assessed over the 12-week study period.
Measured: From enrollment to the end of treatment at 4 weeks.
Change in sleep quality and disturbances based on the Pittsburgh Sleep Quality Index (PSQI):
This study will provide preliminary evidence of the independent and concomitant effects of CBD on improving sleep based on the Pittsburgh Sleep Quality Index (PSQI). This 19-item scale assesses sleep quality and disturbances over a 1-week time interval. The items generate seven "component" scores, including: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: From enrollment to the end of treatment at 4 weeks.
Changes in insomnia symptoms based on the Insomnia Severity Index.
This study will provide preliminary evidence of the independent and concomitant effects of CBD on improving sleep based on the following self-report assessments. Changes in insomnia symptoms will be estimated using the Insomnia Severity Index (ISI). This 7-item scale assesses the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early morning awakenings), satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Measured: From enrollment to the end of treatment at 4 weeks.
Average of acceptability to study procedures score based on feasibility and acceptability study forms
This study will collect data on the acceptability of the study procedures which examine adherence to the study protocols, including acceptability of study procedures (e.g., adjustment of daily activities to participate in the study and levels of engagement) using standardized forms designed by the research team and based on prior studies. The form is a 7-point 15 item scale that will be conducted during six in-person and two phone assessments.
Measured: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Percentage of participants reporting levels of adherence to study procedures based on feasibility and acceptability study forms
This study will collect weekly data on the feasibility and acceptability (F\&A) form of the study procedures which examine levels (low, middle and high) of adherence to the study protocols, including missing doses and adherence to procedures (e.g., completion of lab and questionnaire assessments, adherence to recommended doses) using a 15-item standardized form designed by the research team and based on prior studies. Patients will be asked to return unused medications every other week when the new product is dispensed. The research team will check the returned medications against the usage recorded. Any discrepancies will be discussed with the patient and documented accordingly within the patient's source documents.
Measured: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start6 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672666
- Sponsor's protocol ID
- IRB202301796
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The approved Informed Consent Form restricts the sharing of individual data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Double-Blind Placebo-Controlled, Randomized, Safety, Efficacy, and Acceptability Trial of a Hemp-Derived Cannabidiol Extract for the Treatment of Anxiety
- ClinicalTrials.gov ID
- NCT06672666
- Acronym / sponsor ID
- IRB202301796
- Conditions
- Anxiety, Generalized Anxiety Disorder, Sleep Problems
- Keywords
- Anxiety, CBD, Cannabidiol, Hemp-Derived Cannabidiol Extract, Generalized Anxiety Disorder, GAD, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 2024 (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 study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.
Detailed description
Approximately one-third (33.1%) of Americans will experience an anxiety disorder at some point in their lifetime. Anxiety disorders are primarily treated with antidepressants or benzodiazepines, but unfortunately, many patients report a partial response or cannot tolerate the side effects of these medications, which include risk for abuse, cognitive impairment, and even death. The therapeutic potential of various compounds derived from the Cannabis sativa plant has generated considerable interest, particularly for managing neuropsychiatric disorders that have limited treatment options. Among these compounds, tetrahydrocannabinol (THC) and cannabidiol (CBD), have received significant attention. CBD has shown a unique pharmacological profile that lacks the potential for abuse associated with THC. Animal and small-scale human studies have demonstrated CBD's anxiolytic, antidepressant, panicolytic, and anticompulsive actions, however more research is needed to investigate the mechanisms of action and determine whether these products represent a safe and effective option for the treatment of anxiety. This study will examine the safety and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires, blood, and urine exams will be used to comprehensively monitor adverse drug events. Clinical measurements will be performed to assess changes in anxiety and sleep quality. This study will also examine whether changes in sleep disturbances precede changes in anxiety symptoms. Participants will complete a comprehensive evaluation for the assessment of relevant medical history, and concomitant medication use. This study will provide information about the dosing and safety profile of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract among individuals with anxiety. In addition, the study will provide preliminary evidence of the independent and concomitant effects of CBD on anxiety symptoms and sleep patterns among individuals with anxiety and finally will assess the feasibility and acceptability of study procedures, including dosing, adherence to the study protocols, and the assessment of anxiety symptoms and sleep disturbances measurements over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemp Derived Cannabidiol Extract | Experimental | Drug: Hemp Derived Cannabidiol ExtractSunFlora's CBD Extract 50mg to 150mg titrated over 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo substance to reflect same consistency as the experimental drug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Any biological sex and ages 18 to 55 years old
- Willing and able to give informed consent for participation in the study
- Willing and able to comply with all study requirements, including willingness to donate blood during the study
- Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A)
- Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation.
Key exclusion criteria (16 listed)
- Pregnancy or breastfeeding
- Any history of suicidal behavior or any suicidal ideation in the past six months or at screening
- Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of baseline visit.
- Active daily or almost daily (3+ days/week) use of cannabinoids or THC in the past month or any other illicit drug within the past 6 months
- Inability to refrain from using alcohol (4 or more drinks in one occasion or 3+ days/week), antiepileptics, antipsychotics, oral antifungals, verapamil, nitrofurantoin, or any other medication in drug classes, such as antibiotics, nonsteroidal anti-inflammatory drugs, herbal and dietary supplements, cardiovascular drugs, central nervous system agents, or antineoplastic drugs, inducing transaminase elevation based on the LiverTox database. 17,18
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 |
|---|---|---|
| Hemp Derived Cannabidiol ExtractAlso: SunFlora CBD ExtractParticipants will be given the study drug in a titrated method of 50-150mgs per day for 4 weeks | Drug | Hemp Derived Cannabidiol Extract |
| PlaceboPartcipants will be given placebo substance to be taken with titrated instructions that mimic IP dispensing method daily for 4 weeks | Drug | Placebo |
Primary outcome
Average CBD dose (mgs) used in the titration phase as reported in participant forms.
Time frame: From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).
This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (from 50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the titration phase, participants will be instructed to use an initial dosing of 50 mg/day in the morning progressively increasing 50 mg CBD/day before bedtime as tolerated by the individual participant, up to 150 mg/day by day 14. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.
Average CBD dose (mgs) used in the maintenance phase as indicated and reported in participant forms.
Time frame: From week 2 to the end of maintenance phase at 4 weeks (Day 15 to Day 28)
This trial will inform the dosing of a CBD hemp-based product and its major metabolites following single and multiple doses of a CBD extract (50 to 150 mg/day of CBD) among individuals with anxiety. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. Standardized questionnaires will be used to examine adherence to dosing protocol and potential changes due to side effects. During the maintenance phase, participants will stay at the optimal tolerated dose (between 50-150 mg) for two additional weeks. If a patient experiences mild side effects at doses at or higher than 50 mg daily, the investigators will monitor and may consider temporarily or permanently reducing the dose for the remainder of the study to the doses tolerated. Participants will report the daily doses used on a weekly basis in a dosing sheet.
Percentage of Severity of treatment-related adverse events based on the side effects/adverse events checklist, laboratory test, and self-report of unexpected ADE
Time frame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84)
The safety and tolerability will be determined in eight-assessments conducted during a 12-week period, and based on the side effects/adverse events checklist, laboratory tests, and self-reports of unexpected adverse drug events (ADEs). The type of treatment-related adverse events based will be characterized based on those assessments. The side effects/adverse events will be categorized as: no ADEs, mild (i.e., no intervention required; no impact on activities of daily living), moderate (minimal, local, or non-invasive intervention indicated; moderate impact on activities of daily living) or severe (i.e., significant symptoms requiring invasive intervention; subject seeks medical attention, needs major assistance).
Percentage of patients reporting Drug-Induced Liver Injury based on liver chemistries
Time frame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
In this study, patients are going to be followed for 84 days after treatment initiation, with serum liver chemistries assessments at baseline, and in four subsequent visits (visits 3, 5, 6 and 8), with the last serum liver chemistries 49 days after the last doses. The result is reported as the number of participants that had a clinically significant clinically significant elevation in serum liver chemistries (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) >2 times ULN, Total serum bilirubin >2.5 mg/dL with elevated AST, ALT or ALP; or International normalized ratio (INR) >1.5 with elevated AST, ALT or ALP.
Percentage of severity of depression symptoms based on the Patient Health Questionnaire-9
Time frame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
The Patient Health Questionnaire-9 is a 9-item scale useful for the assessment of the presence and severity of depressive symptom, and a possible depressive disorder. Each of the nine items reflects a DSM-5 symptom of depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Percentage of participants reporting suicidal ideation and behavior based on the Columbia Suicide Severity Rating Scale
Time frame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
The Columbia Suicide Severity Rating Scale (C-SSRS) is a 6-item scale that assesses suicidal ideation and behavior by helping to identify specific behaviors that may be indicative of an individual's intent to kill oneself. Four constructs are measured, including: severity of ideation, intensity of ideation, behavior and lethality.
7 secondary outcomes
Change in anxiety symptoms scores based on the Hamilton Anxiety Rating Scale.
Time frame: From enrollment to the end of treatment at 4 weeks
Change in perceived severity of anxiety symptoms and functionality based on the Clinical Global Impression.
Time frame: From enrollment to the end of treatment at 4 weeks
Change in generalized anxiety symptoms and severity based on the Generalized Anxiety Disorder 7 scale
Time frame: From enrollment to the end of treatment at 4 weeks.
Change in sleep quality and disturbances based on the Pittsburgh Sleep Quality Index (PSQI):
Time frame: From enrollment to the end of treatment at 4 weeks.
Changes in insomnia symptoms based on the Insomnia Severity Index.
Time frame: From enrollment to the end of treatment at 4 weeks.
Average of acceptability to study procedures score based on feasibility and acceptability study forms
Time frame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
Percentage of participants reporting levels of adherence to study procedures based on feasibility and acceptability study forms
Time frame: From enrollment to the end of the study period at 12 weeks (Day 1 to Day 84).
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 9 Jul 2026.
- Individual participant dataSharing planned: No. The approved Informed Consent Form restricts the sharing of individual data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemp Derived Cannabidiol Extract in people with Anxiety and Generalized Anxiety Disorder, run by University of Florida at 1 site in United States.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average CBD dose (mgs) used in the titration phase as reported in participant forms. (time frame: From enrollment to the end of titration phase at 2 weeks (Day 1 to Day 14).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.