Pharmacodynamics and clinical effects of cannabidiol for Gastroparesis

Phase 2

Waitlist Available

Led By Michael Camilleri, MD

Research Sponsored by Mayo Clinic

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 4 weeks

Summary

This trial is testing a CBD medication to see if it can help people with stomach issues like gastroparesis and dyspepsia. CBD might improve stomach function by interacting with the body's digestive system. Cannabinoids have been studied for their effects on stomach movement and inflammation, suggesting they could help treat these conditions.

Eligible Conditions

Gastroparesis
Indigestion

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Fasting Gastric Volume

Gastric Accommodation

Gastric Emptying Half-time (T1/2) of Solids

+3 more

Secondary study objectives

Aggregate Symptom Score

Average Daily Vomiting Episodes in Gastroparesis

Mean Daily Epigastric Pain in Functional Dyspepsia

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Pharmacodynamics and clinical effects of cannabidiolActive Control1 Intervention

Cannabidiol will be administered orally twice daily in equally divided doses starting at 2.5mg/kg per day and increasing by 2.5 to 5.0mg/kg every other day until the target dose of 20mg/kg is reached. Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.

Group II: pharmacodynamics and clinical effects of placeboPlacebo Group1 Intervention

Placebo will be administered orally twice daily in equally divided doses starting at 2.5mg/kg per day and increasing by 2.5 to 5.0mg/kg every other day until the target dose of 20mg/kg is reached. Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.

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