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This is a randomized, double-blind, placebo-controlled, study to assess the safety and effects of CHI-560, CHI-563, CHI-564, & CHI-565 versus placebo on sleep quality in healthy adult participants ages 18-55 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHI-560: Total daily dose: 20 mg CBN | Active Comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN |
|
| CHI-563: Total daily dose: 20 mg CBN + 10 mg CBD | Active Comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 5 mg CBD |
|
| CHI-564: Total daily dose: 20 mg CBN + 20 mg CBD | Active Comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 10 mg CBD |
|
| CHI-565: Total daily dose: 20 mg CBN + 100 mg CBD | Active Comparator | 2 units (i.e., 2 gummies). Each gummy: 10 mg CBN + 50 mg CBD |
|
| CHI-660: Placebo | Placebo Comparator | 2 units (i.e., 2 gummies). Each gummy: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBN and CBD | Dietary Supplement | CBN and CBD in Gummy Format |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Median sleep quality rating during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Days 1-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean latency to sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Mean latency to sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Days 1-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Median early morning awakening rating during the IP administration phase (measured via sleep diary completed within 1 hour of awakening each morning). | Median early morning awakening rating during the IP administration phase (measured via sleep diary completed within 1 hour of awakening each morning). | Days 1-7 |
| Symptoms of depression during the IP administration phase (measured with the DASS depression subscale completed at the end of the IP administration phase). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew T Feldner, PhD | Canopy Growth Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remote | Fayetteville | Arkansas | 72701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37796540 | Derived | Bonn-Miller MO, Feldner MT, Bynion TM, Eglit GML, Brunstetter M, Kalaba M, Zvorsky I, Peters EN, Hennesy M. A double-blind, randomized, placebo-controlled study of the safety and effects of CBN with and without CBD on sleep quality. Exp Clin Psychopharmacol. 2024 Jun;32(3):277-284. doi: 10.1037/pha0000682. Epub 2023 Oct 5. |
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| ID | Term |
|---|---|
| D002187 | Cannabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Number of awakenings after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Number of awakenings after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Days 1-7 |
| Mean duration of time spent awake after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Mean duration of time spent awake after sleep onset during the IP administration phase (measured with the Consensus Sleep Diary - Core Version completed within 1 hour of awakening each morning). | Days 1-7 |
| Sleep disturbance during the IP administration phase (measured with the PROMIS completed at the end of the IP administration phase). | Sleep disturbance during the IP administration phase (measured with the PROMIS completed at the end of the IP administration phase). | Days 1-7 |
| Mean daytime fatigue during the IP administration phase (measured with the VAS-F completed approximately 90 minutes before bedtime each day). | Mean daytime fatigue during the IP administration phase (measured with the VAS-F completed approximately 90 minutes before bedtime each day). | Days 1-7 |
Symptoms of depression during the IP administration phase (measured with the DASS depression subscale completed at the end of the IP administration phase). |
| Days 1-7 |
| Symptoms of anxiety during the IP administration phase (measured with the DASS anxiety subscale completed at the end of the IP administration phase). | Symptoms of anxiety during the IP administration phase (measured with the DASS anxiety subscale completed at the end of the IP administration phase). | Days 1-7 |
| Symptoms of general distress during the IP administration phase (measured with the DASS stress subscale completed at the end of the IP administration phase). | Symptoms of general distress during the IP administration phase (measured with the DASS stress subscale completed at the end of the IP administration phase). | Days 1-7 |
| Irritability during the IP administration phase (measured with the BITe completed at the end of the IP administration phase). | Irritability during the IP administration phase (measured with the BITe completed at the end of the IP administration phase). | Days 1-7 |
| Perceived psychological stress during the IP administration phase (measured with the PSS completed at the end of the IP administration phase). | Perceived psychological stress during the IP administration phase (measured with the PSS completed at the end of the IP administration phase). | Days 1-7 |
| Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) will be classified by system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA). | Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) will be classified by system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA). | Days 1-7 |