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CHI-902 for Treatment of Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04086342
Recruitment Status : Withdrawn (Changes in pipeline)
First Posted : September 11, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Centre for Addiction and Mental Health
McMaster University
Information provided by (Responsible Party):
Canopy Health Innovations

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: CHI-902 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial
Estimated Study Start Date : January 24, 2020
Estimated Primary Completion Date : January 26, 2021
Estimated Study Completion Date : January 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: CHI-902
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).
Drug: CHI-902
A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.
Other Name: CBD Oil

Placebo Comparator: Placebo
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).
Drug: Placebo
Placebo is a vehicle oil that will match CHI-902.
Other Name: Placebo Oil




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Systematic Assessment of Side Effects in Clinical Trials (SAFTEE) [ Time Frame: After 10 weeks of treatment. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Adult males or females (≥18 years of age) will be enrolled until the required number of n=160 subjects completing all study procedures is met. Individuals will be included if they:

  1. Meet DSM-5 criteria for SAD
  2. Score >60 on the Liebowitz Social Anxiety Scale (LSAS)

Exclusion Criteria:

  1. 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;
  2. Past or current neurological illness or head trauma;
  3. History of bipolar disorder, psychotic disorder/schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or personality disorder (Cluster A or B);
  4. 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;
  5. Current psychotic symptoms;
  6. Current suicidal ideation or suicide attempt or self-harm behavior in the past year;
  7. Current unstable psychiatric condition;
  8. Substance use disorder in the past 6 months except nicotine
  9. 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;
  10. Regular pharmacological treatment with psychotropic medications except benzodiazepines which may be used as a rescue medication
  11. 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;
  12. Pregnancy or lactation;
  13. 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;
  14. Positive urine during drug screening for drugs of abuse (except benzodiazepines);
  15. Reported history of difficulty with intravenous blood draws;
  16. Allergy to or intolerability of cannabinoids, CBD or other ingredients of the product;
  17. Baseline liver, renal, or hematological laboratory abnormalities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086342


Locations
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Canada, Ontario
MacAnxiety Research Center, McMaster University
Hamilton, Ontario, Canada, L8S 1B8
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Sponsors and Collaborators
Canopy Health Innovations
Centre for Addiction and Mental Health
McMaster University
Investigators
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Study Director: Mark Ware, MD Canopy Health Innovations
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Responsible Party: Canopy Health Innovations
ClinicalTrials.gov Identifier: NCT04086342    
Other Study ID Numbers: H2017-04
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canopy Health Innovations:
Anxiety
Cannabis
Cannabidiol
CBD
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders