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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Recruitment Status : Withdrawn (Changes in pipeline)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

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 11, 2019
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE January 24, 2020
Estimated Primary Completion Date January 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHI-902 for Treatment of Social Anxiety Disorder
Official Title  ICMJE CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Placebo controlled
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE
  • Drug: CHI-902
    A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.
    Other Name: CBD Oil
  • Drug: Placebo
    Placebo is a vehicle oil that will match CHI-902.
    Other Name: Placebo Oil
Study Arms  ICMJE
  • 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).
    Intervention: Drug: CHI-902
  • 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).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 1, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2019)
160
Estimated Study Completion Date  ICMJE January 26, 2021
Estimated Primary Completion Date January 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04086342
Other Study ID Numbers  ICMJE H2017-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canopy Health Innovations
Study Sponsor  ICMJE Canopy Health Innovations
Collaborators  ICMJE
  • Centre for Addiction and Mental Health
  • McMaster University
Investigators  ICMJE
Study Director: Mark Ware, MD Canopy Health Innovations
PRS Account Canopy Health Innovations
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP