Effectiveness of a cannabidiol supplement on sleep and mood in adults
| ISRCTN | ISRCTN15022302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15022302 |
- Submission date
- 15/05/2024
- Registration date
- 20/05/2024
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The study aims to see if a supplement containing cannabinoids could help adults sleep better and improve their overall health.
Who can participate?
Adults between the ages of 18 to 75 years who have occasional sleeplessness
What does the study involve?
The study involves taking the supplement daily for 10 days, followed by a "washout" period of 2 weeks, and then taking the alternative "supplement". Participants also complete a series of questionnaires on sleep and health.
What are the possible benefits and risks of participating?
Benefits include a better understanding of sleep behaviors and overall health. Risks are minimal and include minor side effects from taking the supplement.
Where is the study run from?
The study participants must reside in the USA. This is a home-based study.
When is the study starting and how long is it expected to run?
June 2022 to September 2023
Who is funding the study?
Sanna, LLC
Who is the main contact:
Heather Hausenblas, PhD, hhausen@ju.edu
Contact information
Public, Scientific, Principal Investigator
3525 Pine St
Jacksonville
32205
United States of America
 ORCID ID |
0000-0002-0127-9184 |
|---|---|
| Phone | +1 9048919746 |
| hhausen@ju.edu |
Study information
| Study design | Pilot randomized double-blind placebo-controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effectiveness of a cannabidiol supplement on sleep and mood in adults with nonclinical insomnia: a randomized double-blind placebo-controlled crossover pilot trial |
| Study objectives | Supplement improves sleep, health-related quality of life HRQoL, anxiety, perceived stress, mood, and daytime fatigue. |
| Ethics approval(s) |
Approved 14/09/2022, Sterling IRB (5500 Interstate North Parkway Suite 515, Atlanta, 30328, United States of America; +1 770-690-9491; support@sterlingirb.com), ref: 10333 |
| Health condition(s) or problem(s) studied | Otherwise healthy adults with nonclinical poor sleep |
| Intervention | Participants with nonclinical insomnia symptoms (as determined by the Insomnia Severity Index) will be recruited into a randomized double-blind placebo-controlled crossover trial. The participants will be randomized using a random number function in Excel to assign ID numbers into conditions to either the Cannabinoid Supplement (CS) or Placebo Control (PC) condition for 10 days. All participants will sign an Institutional Approved Informed Consent (Sterling IRB). Following a two-week washout period, the participants will be asked to complete the alternate condition for 10 days. The CS is an oral soft gel that contains 3 mg THC, 6 mg CBN, 10 mg CBD, and 90 mg of a proprietary food-grade terpene blend (https://sannasleep.com/). The PC is an oral soft gel containing medium chain triglyceride (MCT) oil. The supplement is to be taken an hour before nighttime sleep. |
| Intervention type | Supplement |
| Primary outcome measure | Sleep quality measured using the following validated self-report questionnaires at baseline and following each 10-day condition: 1. Insomnia Severity Index (ISI) 2. Pittsburgh Sleep Quality Index (PSQI) 3. Bergen Insomnia Scale (BIS) 4. Restorative Sleep Questionnaire (RSQ) |
| Secondary outcome measures | The following validated self-report secondary outcome measures were assessed at baseline and following each 10-day condition: 1. Health-related quality of life measured using the self-reported CDC Health-related Quality of Life Measure 2. Anxiety measured using the Trait Anxiety Inventory 3. Perceived stress measured using the self-reported Perceived Stress Scale 4. Mood measured using the self-reported Profile of Mood States 5. Daytime fatigue measured using the validated self-reported Flinders Daytime Fatigue Scale 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. |
| Overall study start date | 01/06/2022 |
| Completion date | 13/09/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | Adults (between the ages of 18 to 75 years) with nonclinical insomnia symptoms (as determined by the Insomnia Severity Index) |
| Key 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 |
| Date of first enrolment | 01/10/2022 |
| Date of final enrolment | 01/11/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Jacksonville
32202
United States of America
Sponsor information
Industry
Las Palmas Village Suite
Cantano
00962
United States of America
| Phone | +1 650.666.9599 |
|---|---|
| jmiller@sanna.com | |
| Website | https://sannascience.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 07/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Heather Hausenblas, hhausen@ju.edu |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/02/2025 | 09/06/2025 | Yes | No |
Editorial Notes
09/06/2025: Publication reference added.
16/05/2024: Study's existence confirmed by the Sterling IRB.
