AVE047-22 CBD in Insomnia

A randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of CBD TPM capsules in adults for use in the reduction of insomnia severity

Who can take part?

You may be able to take part if you have insomnia, a condition that can make it difficult to fall asleep, stay asleep, or feel well-rested.

You may be eligible if you:

• Are 18 years of age or older
• Have been diagnosed with, or suspect you have, insomnia
• Have access to a smartphone to complete study questionnaires

You would not be able to take part if:

• You have an unstable or undiagnosed health condition
• You currently use vaping products, cannabis, sedatives, or have high caffeine intake
• You are pregnant or breastfeeding
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether CBD TPM, an investigational over-the-counter medication, may help improve sleep in people with insomnia.

Participants will be randomly assigned to receive the study medication or a placebo.

• Study duration: Approximately 2 months
• Clinic visits: 4 onsite visits
• Telehealth visits: 4 remote visits

The study includes regular assessments throughout the treatment period.

What will I need to do?

If you take part, you will be asked to:

• Take the study medication as two tablets once daily for 8 weeks
• Attend onsite and telehealth study visits
• Take part in assessments, which may include:
• • Blood and urine tests
  • A heart tracing (ECG)
  • Questionnaires about your sleep
• Record your symptoms using an electronic diary

You may receive reimbursement for travel and out-of-pocket expenses related to study visits.

More information

You can read more about this study here:

• ClinicalTrials.gov – Avecho CBD TPM Study