CHI-902 for Treatment of Social Anxiety Disorder

NCT04086342 | Withdrawn Phase 2 DMC

• 1 other identifier: H2017-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Social Anxiety Disorder

Keywords

Anxiety; Cannabis; Cannabidiol; CBD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to endpoint (week 10)

Secondary Outcomes (1)

• Systematic Assessment of Side Effects in Clinical Trials (SAFTEE)

  After 10 weeks of treatment.

Study Arms (2)

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).

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).

Drug: Placebo

Interventions

CHI-902 DRUG

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

Also known as: CBD Oil

CHI-902

Placebo DRUG

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

Also known as: Placebo Oil

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet DSM-5 criteria for SAD
• Score \>60 on the Liebowitz Social Anxiety Scale (LSAS)

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Canopy Growth Corporation: lead
• Centre for Addiction and Mental Health: collaborator
• McMaster University: collaborator

Study Sites (2)

MacAnxiety Research Center, McMaster University

Hamilton, Ontario, L8S 1B8, Canada

Location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders; Marijuana Abuse

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Mark Ware, MD

  Canopy Growth Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 11, 2019
• Study Start: January 24, 2020
• Primary Completion: January 26, 2021
• Study Completion: January 26, 2021
• Last Updated: June 4, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)