Effectiveness of a cannabidiol supplement on sleep and mood in adults

Effectiveness of a cannabidiol supplement on sleep and mood in adults with nonclinical insomnia: a randomized double-blind placebo-controlled crossover pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15022302

Enrollment

Registered

2024-05-20

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otherwise healthy adults with nonclinical poor sleep Other

Interventions

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 wil

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United States of America

Contacts

Public ContactHeather Hausenblas

hhausen@ju.edu+1 9048919746

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026