CHI-902 for Treatment of Social Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT04086342|
Recruitment Status : Withdrawn (Changes in pipeline)
First Posted : September 11, 2019
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder||Drug: CHI-902 Drug: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Placebo controlled|
|Masking:||Double (Participant, Investigator)|
|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|
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).
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).
Placebo is a vehicle oil that will match CHI-902.
Other Name: Placebo Oil
- 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.
- 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.
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
|MacAnxiety Research Center, McMaster University|
|Hamilton, Ontario, Canada, L8S 1B8|
|Centre for Addiction and Mental Health (CAMH)|
|Toronto, Ontario, Canada|
|Study Director:||Mark Ware, MD||Canopy Health Innovations|