Social Anxiety DisorderPhase 2NCT04086342
CHI-902 for Treatment of Social Anxiety Disorder
A Phase 2 study testing CHI-902 in people with Social Anxiety Disorder, run by Canopy Growth Corporation at 2 sites in Canada.
Trial summary
No substantial clinical trials of Cannabidiol (CBD) in Social Anxiety Disorder (SAD) have yet been conducted. This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy, tolerability and safety of CBD oil (CHI-902) in SAD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- CHI-902
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Jan 2020to 26 Jan 2021
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Serious, unstable medical condition including but not limited to cerebrovascular, renal, hepatic, coronary heart disease, coagulation/blood disorders, use of anticoagulant medication, pre-existing cardiovascular disease including poorly controlled hypertension, ischaemic heart disease, arrhythmia, or heart failure;
- Past or current neurological illness or head trauma;
- History of bipolar disorder, psychotic disorder/schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or personality disorder (Cluster A or B);
- Current moderate or severe major depressive episode, panic disorder, generalized anxiety disorder, or post-traumatic stress disorder (PTSD). Traits associated with these disorders are permissible but full DSM criteria should not be met;
- Current psychotic symptoms;
- Current suicidal ideation or suicide attempt or self-harm behavior in the past year;
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- Current unstable psychiatric condition;
- Substance use disorder in the past 6 months except nicotine
- Cannabis use or use of medications or drugs targeting endocannabinoid system including but not limited to nabiximols, nabilone, or synthetic cannabinoids in the past 3 months;
- Regular pharmacological treatment with psychotropic medications except benzodiazepines which may be used as a rescue medication
- Pharmacological treatment with medications with potential significant drug-drug interactions with CBD through Cytochrome P450 metabolization (CYP3A4, CYP2C9, CYP2C19, CYP1A1) based on the Investigator assessment;
- Pregnancy or lactation;
- Males and females of child-bearing potential must be using and willing to continue using medically acceptable contraception throughout the study to avoid pregnancy during the study and for up to 4 weeks after study completion, as described below. Study-acceptable methods of birth control are double-barrier methods, which include a combination of any 2 of the following: oral contraceptives, diaphragm, condom, copper intrauterine device, sponge, spermicide, or (partner's) vasectomy;
- Positive urine during drug screening for drugs of abuse (except benzodiazepines);
- Reported history of difficulty with intravenous blood draws;
- Allergy to or intolerability of cannabinoids, CBD or other ingredients of the product;
- Baseline liver, renal, or hematological laboratory abnormalities.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
MacAnxiety Research Center, McMaster University
Hamilton, Ontario, L8S 1B8
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario
About this study
Official title: CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial
No substantial clinical trials of Cannabidiol (CBD) in Social Anxiety Disorder (SAD) have yet been conducted. This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy, tolerability and safety of CBD oil (CHI-902) in SAD. In addition, the effects of treatment with CHI-902 on the Endocannabinoid System (ECS) will be assessed by evaluating peripheral endocannabinoids (Arachidonoylethanolamide/Anandamide (AEA) and 2-Arachidonoyl glycerol (2-AG)) before and after treatment.
Read the detailed description
This study will evaluate efficacy, therapeutic effects, tolerability and safety of CBD oil in adults with SAD through a randomized placebo-controlled study design and will evaluate effects of CHI-902 on peripheral endocannabinoids (AEA and 2-AG). This study will be the first randomized, double-blind placebo-controlled trial conducted with CHI-902 in adults with SAD.
The study is designed to:
- Evaluate the efficacy of CHI-902 versus placebo in adults with SAD.
- Evaluate the tolerability and safety versus placebo of CHI-902 in adults with SAD.
- Explore the effects of CHI-902 versus placebo on different biomarkers in subjects with SAD.
- Conditions
- Social Anxiety Disorder
- Being tested
- CHI-902, Placebo
- Keywords
- Anxiety, Cannabis, Cannabidiol, CBD
- Medical subject headings
- Phobia, Social, Anxiety Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHI-902Drug
Also called CBD Oil
A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.
PlaceboDrug
Also called Placebo Oil
Placebo is a vehicle oil that will match CHI-902.
| Study group | Role | What they receive |
|---|---|---|
| CHI-902 | Active comparator | Study subjects will enter a titration phase of 1 week with a daily oral CBD dose of 150 mg (50 mg three times daily). Then, daily CBD dose of 300 mg or matching placebo will be given for 3 weeks (treatment phase 1; fixed dose). Receives: Drug: CHI-902 |
| Placebo | Placebo comparator | Study subjects will enter a titration phase of 1 week with a daily oral dose of 150 mg (50 mg three times daily) of matching placebo. Then, daily dose of 300 mg of matching placebo will be given for 3 weeks (treatment phase 1; fixed dose). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale (LSAS)
Quantitative change in LSAS total score from baseline to endpoint (week 10) in subjects receiving active treatment with CHI-902 compared to subjects receiving placebo.
The scale is composed of 24 items divided into 2 subscales, 13 concerning performance anxiety, and 11 pertaining to social situations. The 24 items are first rated on a scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points. Research supports a cut-off point of 30, in which SAD is unlikely. The next cut-off point is at 60, at which SAD is probable. Scores between 60 and 90 indicate that SAD is very probable. Scores higher than 90 indicate that SAD is highly probable.
Measured: Baseline to endpoint (week 10)
Secondary outcomes (1)
Systematic Assessment of Side Effects in Clinical Trials (SAFTEE)
Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE). Tolerability of treatment assessed by SAFTEE in subjects receiving active treatment with CHI-902 compared to subjects receiving placebo, and safety through number of subjects dropping out due to SAEs in the two groups.
Measured: After 10 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start24 Jan 2020 (estimated)
- Primary completion26 Jan 2021 (estimated)
- Study completion26 Jan 2021 (estimated)
Why it stopped: Changes in pipeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Addiction and Mental Health, McMaster University
- Responsible party
- Sponsor
- Investigators
- Mark Ware, MD, Study director, Canopy Growth Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086342
- Sponsor's protocol ID
- H2017-04
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04086342
- Acronym / sponsor ID
- H2017-04
- Conditions
- Social Anxiety Disorder
- Keywords
- Anxiety, Cannabis, Cannabidiol, CBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in pipeline
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Addiction and Mental Health, McMaster University
- Study start
- 24 Jan 2020 (estimated)
- Primary completion
- 26 Jan 2021 (estimated)
- Study completion
- 26 Jan 2021 (estimated)
- First posted
- 11 Sep 2019 (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.
No substantial clinical trials of Cannabidiol (CBD) in Social Anxiety Disorder (SAD) have yet been conducted. This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy, tolerability and safety of CBD oil (CHI-902) in SAD. In addition, the effects of treatment with CHI-902 on the Endocannabinoid System (ECS) will be assessed by evaluating peripheral endocannabinoids (Arachidonoylethanolamide/Anandamide (AEA) and 2-Arachidonoyl glycerol (2-AG)) before and after treatment.
Detailed description
This study will evaluate efficacy, therapeutic effects, tolerability and safety of CBD oil in adults with SAD through a randomized placebo-controlled study design and will evaluate effects of CHI-902 on peripheral endocannabinoids (AEA and 2-AG). This study will be the first randomized, double-blind placebo-controlled trial conducted with CHI-902 in adults with SAD.
The study is designed to:
- Evaluate the efficacy of CHI-902 versus placebo in adults with SAD.
- Evaluate the tolerability and safety versus placebo of CHI-902 in adults with SAD.
- Explore the effects of CHI-902 versus placebo on different biomarkers in subjects with SAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| CHI-902 | Active comparator | Drug: CHI-902Study subjects will enter a titration phase of 1 week with a daily oral CBD dose of 150 mg (50 mg three times daily). Then, daily CBD dose of 300 mg or matching placebo will be given for 3 weeks (treatment phase 1; fixed dose). |
| Placebo | Placebo comparator | Drug: PlaceboStudy subjects will enter a titration phase of 1 week with a daily oral dose of 150 mg (50 mg three times daily) of matching placebo. Then, daily dose of 300 mg of matching placebo will be given for 3 weeks (treatment phase 1; fixed dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Serious, unstable medical condition including but not limited to cerebrovascular, renal, hepatic, coronary heart disease, coagulation/blood disorders, use of anticoagulant medication, pre-existing cardiovascular disease including poorly controlled hypertension, ischaemic heart disease, arrhythmia, or heart failure;
- Past or current neurological illness or head trauma;
- History of bipolar disorder, psychotic disorder/schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or personality disorder (Cluster A or B);
- Current moderate or severe major depressive episode, panic disorder, generalized anxiety disorder, or post-traumatic stress disorder (PTSD). Traits associated with these disorders are permissible but full DSM criteria should not be met;
- Current psychotic symptoms;
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 |
|---|---|---|
| CHI-902Also: CBD OilA standardized cannabis extract in MCT oil administered in oral liquid (oil) form. | Drug | CHI-902 |
| PlaceboAlso: Placebo OilPlacebo is a vehicle oil that will match CHI-902. | Drug | Placebo |
Primary outcome
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Baseline to endpoint (week 10)
Quantitative change in LSAS total score from baseline to endpoint (week 10) in subjects receiving active treatment with CHI-902 compared to subjects receiving placebo. The scale is composed of 24 items divided into 2 subscales, 13 concerning performance anxiety, and 11 pertaining to social situations. The 24 items are first rated on a scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points. Research supports a cut-off point of 30, in which SAD is unlikely. The next cut-off point is at 60, at which SAD is probable. Scores between 60 and 90 indicate that SAD is very probable. Scores higher than 90 indicate that SAD is highly probable.
1 secondary outcome
Systematic Assessment of Side Effects in Clinical Trials (SAFTEE)
Time frame: After 10 weeks of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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.
Mark Ware, MD study director
Canopy Growth Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHI-902 in people with Social Anxiety Disorder, run by Canopy Growth Corporation at 2 sites 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 0 inclusion and 17 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: withdrawn, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Liebowitz Social Anxiety Scale (LSAS) (time frame: Baseline to endpoint (week 10)). 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 4 Jun 2020.