A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of CBN With and Without CBD on Sleep Quality

Healthy Adults Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of CBN With and Without CBD on Sleep Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839964
• Other study ID #: 710US-1501
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 16, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: April 2023
• Source: Canopy Growth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Person is between 18 and 55-years-old (inclusive).

2. Person has a BMI between 18 and 35 kg/m2 (inclusive).

3. Person is willing and able to provide informed consent.

4. Woman of childbearing potential must not be pregnant or currently breastfeeding.

5. Person agrees to abide by all study restrictions and comply with all study procedures.

6. Person rates past-week sleep quality on a 1 (very poor) to 5 (very good) rating scale as poor (2) or very poor (1).

Exclusion Criteria:

1. Person has a known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, hemp products, or excipients of the IP.

2. Person has been exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future (within 30 days).

3. Person has had a change in allowable medication, caffeine, tobacco, alcohol, supplement, or other drug use dose or regimen within 30 days of screening or has any plans to change dose or regimen during the course of the study.

4. Person has used cannabis, cannabinoid analogue (e.g., dronabinol, nabilone), and/or any CBD- or delta-9-tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.

5. Person has history of use of any synthetic cannabinoid receptor agonist (e.g., spice, K2) within the past year.

6. Person is currently using products or medications that may interact with one or more of the ingredients in the IP, including the following drugs or supplements: warfarin, clobazam, valproic acid, phenobarbital, mechanistic target of rapamycin [mTOR] inhibitors, oral tacrolimus, St. John's wort, and Epidiolex.

7. Person has a positive screen (i.e., exceeds cut-point score) for any of the following sleep disorders on the Sleep Disorders Symptom Checklist-17 (SDS-CL-17): narcolepsy, obstructive sleep apnea, restless legs syndrome.

8. Person has a personal or family history (first-degree relative) of a psychotic disorder and/or schizophrenia.

9. Person endorses current suicidal intent as indexed via items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).

10. Person has an acute or progressive disease or disorder that is likely to interfere with the objectives of the study, or the ability to adhere to protocol requirements.

11. Person has a history of cardiovascular disease.

12. Woman of childbearing potential, unless she has not engaged in vaginal intercourse or she has used effective contraception when doing so (for example, oral contraception, double barrier, intra-uterine device) for at least 30 days prior to the study.

13. Woman of childbearing potential, unless willing to ensure that she or her partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).

14. Man whose partner is of childbearing potential, unless willing to ensure that he or his partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).

15. Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >5 · upper limit of normal [ULN] or total bilirubin [TBL] >2 · ULN) OR the ALT or aspartate aminotransferase (AST) >3 · ULN and TBL >2 · ULN (or international normalized ratio [INR] >1.5).

16. Person demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• CBN and CBD
CBN and CBD in Gummy Format

Locations

Country	Name	City	State
United States	Remote	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Canopy Growth Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Symptoms of depression during the IP administration phase (measured with the DASS depression subscale completed at the end of the IP administration phase).	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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