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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will take defined cbd at least four times per week over a total time period of four weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Time Spent in Slow Wave (Deep) and REM Sleep

Secondary study objectives

Objective Measures of Sleep Physiology

Subjective Measure of Sleep Physiology

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Do I qualify?Apply below to find out