Effectiveness of a cannabidiol supplement on sleep and mood in adults

Not Applicable

Completed

Conditions: Otherwise healthy adults with nonclinical poor sleep
Not Applicable

Registration Number: ISRCTN15022302

Lead Sponsor: Sanna, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

Adults (between the ages of 18 to 75 years) with nonclinical insomnia symptoms (as determined by the Insomnia Severity Index)

Exclusion Criteria

1. Severe insomnia (based on the Insomnia Severity Index (ISI = 22) or nonclinical insomnia (ISI < 8)
2. History of a diagnosed disorder affecting sleep quality
3. Reported events that could cause severe stress within 2 weeks of baseline
4. Use of medication that could influence sleep patterns within 1 month of the trial
5. Use of hormone therapy
6. Binge alcohol consumption
7. Smoking
8. High caffeine intake
9. Work schedule that causes irregular sleep patterns
10. History of travel to a different time zone within 1 month of the study
11. Low or high body mass index (BMI = 18 kg/m2 or = 35 kg/m2)
12. Pregnant, trying to conceive, or breastfeeding
13. Taking sleep supplements or medication
14. Unwilling to abstain from other cannabis/hemp product use for two weeks prior to and during the trial
15. Individuals deemed unable to complete the protocol as designed

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality measured using the following validated self-report questionnaires at baseline and following each 10-day condition:<br>1. Insomnia Severity Index (ISI)<br>2. Pittsburgh Sleep Quality Index (PSQI)<br>3. Bergen Insomnia Scale (BIS)<br>4. Restorative Sleep Questionnaire (RSQ)

Secondary Outcome Measures

Name	Time	Method
The following validated self-report secondary outcome measures were assessed at baseline and following each 10-day condition:<br>1. Health-related quality of life measured using the self-reported CDC Health-related Quality of Life Measure<br>2. Anxiety measured using the Trait Anxiety Inventory <br>3. Perceived stress measured using the self-reported Perceived Stress Scale<br>4. Mood measured using the self-reported Profile of Mood States <br>5. Daytime fatigue measured using the validated self-reported Flinders Daytime Fatigue Scale <br><br>Safety/adverse events were measured using the following open-ended question; Did you experience any adverse events: Yes No. If yes, please indicate what the event was” daily.