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Cannabinoid

Defined CBD for Insomnia

Phase 2
Waitlist Available
Research Sponsored by Defined Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will take defined cbd at least four times per week over a total time period of four weeks.
Awards & highlights

Study Summary

Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too early in the morning, or having unrefreshing sleep. Defined CBD is a capsule composed of highly purified (>99.9%) hemp-derived cannabidiol (CBD) and terpenes produced as a potential sleep aid for people with insomnia. This product contains no detectable Delta-9-tetrahydrocannabinol (Delta-9-THC). This trial is specifically designed to evaluate the efficacy of Defined CBD on sleep physiology in people with insomnia.

Eligible Conditions
  • Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will take defined cbd at least four times per week over a total time period of four weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will take defined cbd at least four times per week over a total time period of four weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Time Spent in Slow Wave (Deep) and REM Sleep
Secondary outcome measures
Objective Measures of Sleep Physiology
Subjective Measure of Sleep Physiology

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Defined CBDExperimental Treatment1 Intervention
Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.
Group II: PlaceboPlacebo Group1 Intervention
The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules.

Find a Location

Who is running the clinical trial?

Defined ResearchLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Defined Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
2022. "Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233761.
All > Insomnia
~39 spots leftby Apr 2025
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