Generalized Anxiety DisorderPhase 3NCT03549819
Cannabidiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study
A Phase 3 study testing Cannabidiol (CBD) Oil Capsules and Sunflower Lecithin Oil in Capsule in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by McMaster University at 1 site in Canada.
Trial summary
This proposed study aims to evaluate the efficacy of daily Cannabidiol (CBD) Oil Capsules in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Cannabidiol (CBD) Oil Capsules and Sunflower Lecithin Oil in Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2021to Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients 21-65 years of age with a primary psychiatric diagnosis of either GAD, SAD, PD or agoraphobia as defined by DSM-5 criteria and a HAM-A score of ≥ 22.
- Physical exam and laboratory findings without clinically significant abnormalities.
- Participants must agree to abstain from recreational cannabis use for the duration of the study.
- Concomitant psychotropic medication use will be allowed provided that the dose has been stable for 8 weeks prior to randomization. (including antidepressants, anti-psychotics, anti-convulsants, benzodiazepines, stimulants, mood stabilizers)
- The ability to comprehend and satisfactorily comply with protocol requirements.
- Written informed consent given prior to entering the baseline period of the study.
Who cannot join
- Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
- Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder)will be excluded.
- Participants with a lifetime history of daily cannabis use will be excluded.
- Dose changes of concomitant medication will not be permitted during the study period.
- Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant.
- Diagnosis of any of the following mental disorders as defined by the DSM-5: a lifetime history of schizophrenia or any other psychosis, mental retardation, organic medical disorders, bipolar disorder. Entry of patients with obsessive compulsive disorder or posttraumatic stress disorder will be permitted if the anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
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- Major depression will be allowed if not severe (Montgomery Asberg Depression Rating Scale-MADRS ≥ 25). Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviours within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Participants with a family history of psychosis will be excluded.
- Participants who have a history of adverse reactions to cannabis will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B7
Beth Patterson, MSc, 905-921-7644, bpatter@mcmaster.ca
Michael Van Ameringen, MD, FRCPC
About this study
This proposed study aims to evaluate the efficacy of daily Cannabidiol (CBD) Oil Capsules in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and CBD using biological markers as well as examine the neuro-cognitive effects of CBD treatment.
Read the detailed description
The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of flexibly dosed CBD Oil capsules versus placebo for the treatment of adults, aged 21 to 65 years with a primary Diagnostic and Statistical Manual 5 (DSM-5) anxiety disorder: Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), or agoraphobia. A total 50 participants (n=25/cell) who meet the inclusion criteria will be randomized to receive 1 of 2 treatments in a 1:1 ratio: CBD Oil Capsules or matching placebo, with the possibility of dose titration during this 8-week period. The outcomes of this research will make a significant contribution to enhance our current understanding of the effects of cannabis in anxiety disorders.
To be involved in this study, the study doctor will first check that the participant is qualified. This is called screening, and will involve a clinical assessment, physical exam and urine tests. This visit may take up to 3 hours to complete.
If the participant successfully completes screening the participant will start treatment in one of the two assigned treatment groups. Treatment is 8 weeks. Participants will come to the study clinic 6 times during the treatment phase of the study. Each visit will last 1 to 2 hours. Each visit will involve reporting any side effects that the participant may have experienced, completing questionnaires about mood and anxiety symptoms, sleep, overall functioning and alcohol and drug use. Participants will also be assessed by the study doctor. The first and last visits will also involve blood work and completing a number of tasks on the computer, which measure focus, attention and memory.
Each participant will be involved in the study for a maximum of 10 weeks. This includes the screening visit and follow-up visit.
- Being tested
- Cannabidiol (CBD) Oil Capsules, Sunflower Lecithin Oil in Capsule
- Keywords
- Anxiety Disorders, Cannabidiol, Cannabis
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Agoraphobia, Anxiety Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD) Oil CapsulesDrug
200 mg CBD- titrated as tolerated up to a maximum 2 capsules twice daily (200 mg- 800 mg total dose)
Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)
Sunflower Lecithin Oil in CapsuleDrug
Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) Oil Capsules | Experimental | Pure CBD in sunflower lecithin oil, flexibly dosed at 200-800 mg per day Receives: Drug: Cannabidiol (CBD) Oil Capsules |
| Sunflower Lecithin Oil in Capsule | Placebo comparator | 1-4 capsules daily Receives: Drug: Sunflower Lecithin Oil in Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAM-A)
The 14-item HAM-A was developed to assess general anxiety symptoms in a clinical population and has proven sensitive to change with treatment. It is a clinician-rated measure and will be administered at each visit by a trained, blinded rater, using the Structured Interview Guide for the HAM-A. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) are summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Measured: Change from baseline to week 8
Secondary outcomes (27)
Clinical Global Impression - Severity (CGI-S)
The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not ill) to 7 (among the most severely ill).
Measured: Change from baseline to week 8
Clinical Global Impression - Improvement (CGI-I)
The CGI-I is a clinician-rated instrument used to assess overall improvement of illness. The CGI-I ranges from 1 (very much improved) to 7 (very much worse).
Measured: Change from baseline to week 8
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a self-reported questionnaire that measures the severity of various signs of GAD. It contains seven items with a 4-point scale (range: 0 to 3). The total possible score is ranged from 0 to 21, with higher scores representing greater severity of GAD.
Measured: Change from baseline to week 8
Liebowitz Social Anxiety Scale- Self Report (LSAS-SR)
The LSAS-SR is a 24 item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS-SR contains three total scores 1) total fear score (0-72), 2) total avoidance score (0-72) and total overall score (0-144).
Measured: Change from baseline to week 8
Panic and Agoraphobia Scale (PAS)
The PAS is a measure of the severity of illness in patients with panic disorder (with or without agoraphobia). It has 13 items with a 5-point scale (range: 0-4). The total possible score is ranged from 0 to 52, with higher scores representing increased severity of illness. It contains 5 sub-scales: panic attacks, agoraphobic avoidance, anticipatory anxiety, disability, and functional avoidance (health concerns).
Measured: Change from baseline to week 8
Quick Inventory of Depressive Symptomology (QIDS)
The QIDS is a self-report measure of depression. It contains 16 items with a 4-point scale (range: 0 to 3) which assess the severity of the nine diagnostic symptom criteria used in the DSM: Sleep disturbance, sad mood, decrease/increase in appetite/weight, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, and psychomotor agitation/retardation. The total possible score is ranged from 0 to 27, with higher scores representing greater severity of depression.
Measured: Change from baseline to week 8
Sheehan Disability Scale (SDS)
The SDS is a 3 question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Each sub-scale score ranges from 0 to 10 and a total disability score, calculated as the sum of scores for each question ranges from 0 to 30. Higher scores reflect greater impairment.
Measured: Change from baseline to week 8
World Health Organization Disability Assessment Scale (WHODAS 2.0)
The WHODAS 2.0 is a 36-item self-administered questionnaire that covers 6 domains of functioning, including: Cognition, mobility, self-care, getting along with people, life activities, participation. Each question ranges from 'none' to 'extreme or cannot do'. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed to give a total score that ranges from 0 to 144, with higher scores representing a greater degree of functional limitation.
Measured: Change from baseline to week 8
Insomnia Severity Index (ISI)
The ISI has 7 questions with a 5-point score (range: 0 to 4). The total possible score is ranged from 0 to 28, with higher scores reflecting greater severity of sleep difficulty.
Measured: Change from baseline to week 8
Marijuana Craving Questionnaire
The Marijuana Craving Questionnaire is a 47-item self-report instrument that assesses marijuana craving along four dimensions: compulsivity, emotionality, expectancy, and purposefulness. Each item is answered with a 7-point scale from 1 (strongly disagree) to 7 (strongly agree).
Measured: Change from baseline to week 8
Obsessive Compulsive Inventory-Revised (OCI-R)
The OCI-R is a self-report scale for assessing symptoms of Obsessive-Compulsive Disorder (OCD). It consists of 18 questions with a 5-point scale (range: 0 to 4). The possible range of scores is 0 to 72, with higher scores indicating a greater likelihood of the presence of OCD.
Measured: Change from baseline to week 8
PTSD Checklist (PCL-5)
The PCL-5 is a 20 item self-report measure that assesses symptoms of PTSD. Each item is rated on a 5-point scale from 0 (not at all) to 4 (extremely). The possible range of scores is 0 to 80, with higher scores indicating greater severity of PTSD.
Measured: Change from baseline to week 8
Drug Effects Questionnaire (DEQ)
The DEQ assesses the extent to which participants 1) feel any substance effect(s), 2) feel high, 3) like the effects, 4) dislike the effects, and 5) want more of the substance using 100mm Visual Analog Scales.
Measured: Change from baseline to week 8
Marijuana Withdrawal Checklist
The Marijuana Withdrawal Checklist has 22 items that assess mood, behavioural, and physical symptoms associated with marijuana withdrawal. Each item is rated on a 4-point scale from 0 (none) to 3 (severe). A total score is obtained by summing each of the item totals (range 0 to 66). Higher scores indicated more severe symptoms associated with marijuana withdrawal.
Measured: Change from baseline to week 8
Shipley II: Verbal
Measures verbal intelligence quotient (IQ) - crystallized intelligence
Measured: Baseline
Shipley II: Abstraction
Measures abstract intelligence quotient (IQ) - fluid intelligence
Measured: Baseline
Digits Forward Test
Measures attention
Measured: Change from baseline to week 8
Digits Backward Test
Measures working memory
Measured: Change from baseline to week 8
Go/No-Go Test
Measures behavioural inhibition
Measured: Change from baseline to week 8
Monetary Choice Questionnaire
Measures impulsive decision making
Measured: Change from baseline to week 8
Probabilistic Choice Questionnaire
Measures risky decision making
Measured: Change from baseline to week 8
Trails A and B Task
Measures visual attention and switching
Measured: Change from baseline to week 8
Rey Auditory Verbal Learning Test
Measures short-term auditory-verbal memory
Measured: Change from baseline to week 8
Simple Visual Reaction Time Task
Measures reaction time
Measured: Change from baseline to week 8
Sustained Attention to Response Task
Measures sustained attention
Measured: Change from baseline to week 8
Experimental Drug Purchase Task
Measures drug abuse liability
Measured: Week 8
Inflammatory Markers
Serum levels of IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α and IFN-γ
Measured: Change from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start15 Dec 2021
- Primary completion15 Dec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Tilray
- Responsible party
- Sponsor
- Investigators
- Michael Van Ameringen, MD, FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549819
- Sponsor's protocol ID
- CBD_ANX
- Status last verified
- Feb 2023
- First submitted
- 15 May 2018
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study
- ClinicalTrials.gov ID
- NCT03549819
- Acronym / sponsor ID
- CBD_ANX
- Keywords
- Anxiety Disorders, Cannabidiol, Cannabis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Tilray
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 8 Jun 2018 (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 proposed study aims to evaluate the efficacy of daily Cannabidiol (CBD) Oil Capsules in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and CBD using biological markers as well as examine the neuro-cognitive effects of CBD treatment.
Detailed description
The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of flexibly dosed CBD Oil capsules versus placebo for the treatment of adults, aged 21 to 65 years with a primary Diagnostic and Statistical Manual 5 (DSM-5) anxiety disorder: Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), or agoraphobia. A total 50 participants (n=25/cell) who meet the inclusion criteria will be randomized to receive 1 of 2 treatments in a 1:1 ratio: CBD Oil Capsules or matching placebo, with the possibility of dose titration during this 8-week period. The outcomes of this research will make a significant contribution to enhance our current understanding of the effects of cannabis in anxiety disorders.
To be involved in this study, the study doctor will first check that the participant is qualified. This is called screening, and will involve a clinical assessment, physical exam and urine tests. This visit may take up to 3 hours to complete.
If the participant successfully completes screening the participant will start treatment in one of the two assigned treatment groups. Treatment is 8 weeks. Participants will come to the study clinic 6 times during the treatment phase of the study. Each visit will last 1 to 2 hours. Each visit will involve reporting any side effects that the participant may have experienced, completing questionnaires about mood and anxiety symptoms, sleep, overall functioning and alcohol and drug use. Participants will also be assessed by the study doctor. The first and last visits will also involve blood work and completing a number of tasks on the computer, which measure focus, attention and memory.
Each participant will be involved in the study for a maximum of 10 weeks. This includes the screening visit and follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) Oil Capsules | Experimental | Drug: Cannabidiol (CBD) Oil CapsulesPure CBD in sunflower lecithin oil, flexibly dosed at 200-800 mg per day |
| Sunflower Lecithin Oil in Capsule | Placebo comparator | Drug: Sunflower Lecithin Oil in Capsule1-4 capsules daily |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female outpatients 21-65 years of age with a primary psychiatric diagnosis of either GAD, SAD, PD or agoraphobia as defined by DSM-5 criteria and a HAM-A score of ≥ 22.
- Physical exam and laboratory findings without clinically significant abnormalities.
- Participants must agree to abstain from recreational cannabis use for the duration of the study.
- Concomitant psychotropic medication use will be allowed provided that the dose has been stable for 8 weeks prior to randomization. (including antidepressants, anti-psychotics, anti-convulsants, benzodiazepines, stimulants, mood stabilizers)
- The ability to comprehend and satisfactorily comply with protocol requirements.
Key exclusion criteria (9 listed)
- Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
- Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder)will be excluded.
- Participants with a lifetime history of daily cannabis use will be excluded.
- Dose changes of concomitant medication will not be permitted during the study period.
- Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant.
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) Oil Capsules200 mg CBD- titrated as tolerated up to a maximum 2 capsules twice daily (200 mg- 800 mg total dose) Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose) | Drug | Cannabidiol (CBD) Oil Capsules |
| Sunflower Lecithin Oil in CapsuleStart at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose) | Drug | Sunflower Lecithin Oil in Capsule |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Change from baseline to week 8
The 14-item HAM-A was developed to assess general anxiety symptoms in a clinical population and has proven sensitive to change with treatment. It is a clinician-rated measure and will be administered at each visit by a trained, blinded rater, using the Structured Interview Guide for the HAM-A. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) are summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
27 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Time frame: Change from baseline to week 8
Clinical Global Impression - Improvement (CGI-I)
Time frame: Change from baseline to week 8
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Change from baseline to week 8
Liebowitz Social Anxiety Scale- Self Report (LSAS-SR)
Time frame: Change from baseline to week 8
Panic and Agoraphobia Scale (PAS)
Time frame: Change from baseline to week 8
Quick Inventory of Depressive Symptomology (QIDS)
Time frame: Change from baseline to week 8
Sheehan Disability Scale (SDS)
Time frame: Change from baseline to week 8
World Health Organization Disability Assessment Scale (WHODAS 2.0)
Time frame: Change from baseline to week 8
Insomnia Severity Index (ISI)
Time frame: Change from baseline to week 8
Marijuana Craving Questionnaire
Time frame: Change from baseline to week 8
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: Change from baseline to week 8
PTSD Checklist (PCL-5)
Time frame: Change from baseline to week 8
Drug Effects Questionnaire (DEQ)
Time frame: Change from baseline to week 8
Marijuana Withdrawal Checklist
Time frame: Change from baseline to week 8
Shipley II: Verbal
Time frame: Baseline
Shipley II: Abstraction
Time frame: Baseline
Digits Forward Test
Time frame: Change from baseline to week 8
Digits Backward Test
Time frame: Change from baseline to week 8
Go/No-Go Test
Time frame: Change from baseline to week 8
Monetary Choice Questionnaire
Time frame: Change from baseline to week 8
Probabilistic Choice Questionnaire
Time frame: Change from baseline to week 8
Trails A and B Task
Time frame: Change from baseline to week 8
Rey Auditory Verbal Learning Test
Time frame: Change from baseline to week 8
Simple Visual Reaction Time Task
Time frame: Change from baseline to week 8
Sustained Attention to Response Task
Time frame: Change from baseline to week 8
Experimental Drug Purchase Task
Time frame: Week 8
Inflammatory Markers
Time frame: Change from baseline to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Michael Van Ameringen, MD, FRCPC principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabidiol (CBD) Oil Capsules and Sunflower Lecithin Oil in Capsule in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by McMaster University at 1 site in Canada.
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 9 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: Change from baseline to week 8). 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 14 Feb 2023.