CHI-902 for Treatment of Social Anxiety Disorder

NCT ID: NCT04086342

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2021-01-26

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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

CHI-902

Intervention Type: DRUG

A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is a vehicle oil that will match CHI-902.

Interventions

CHI-902

A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.

Intervention Type: DRUG

Placebo

Placebo is a vehicle oil that will match CHI-902.

Intervention Type: DRUG

Other Intervention Names

CBD Oil; Placebo Oil

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Canopy Growth Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Ware, MD

Role: STUDY_DIRECTOR

Canopy Growth Corporation

Locations

MacAnxiety Research Center, McMaster University

Hamilton, Ontario, Canada

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

H2017-04

Identifier Type: -

Identifier Source: org_study_id