A Study to Evaluate the Effectiveness and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

Overview

About this study

The purpose of this study is to to evaluate the effectiveness and safety of cannabidiol for gastroparesis and functional dyspepsia.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Ability to provide informed consent.
  • Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results.
  • Body mass index of 18-40 kg/m^2.
  • Females must not be pregnant or lactating due to administration of study medications and radiation exposure.
  • Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are permissible.
  • Also subject will be included if they are on [KLA1] stable (no change in past month) doses of the following medications listed below:
    • Amitriptyline up to 25mg per 24 hours;
    • Nortriptyline up to 25mg per 24 hours;
    • Paroxetine up to 50mg per 24 hours;
    • Escitalopram up to 20 mg per 24 hours;
    • Bupropion up to 300mg per 24 hours;
    • Citalopram up to 40 mg per 24 hours;
    • Fluoxetine up to 60 mg per 24 hours;
    • Sertaline up to 100 mg per 24 hours;
    • Fluvoxamine up to 100 mg daily.
  • Specific eligibility criteria regarding gastric emptying (320kcal, 30% fat meal) in different specific aims will be:
    • For gastroparesis (aims 1a ): < 25% emptied at 2 hours, and/or > 25% retained at 4 hours;
    • For functional dyspepsia (aim 1b): < 25% retained at 4 hours (i.e., normal gastric emptying of solids).
  • Participants will have baseline screening for anxiety and depression by questionnaire.

Exclusion Criteria:

  • Patients with current H. pylori infection will be excluded.
  • Pregnancy or lactation.
  • Rapid metabolizers for CYP3A4 or CYP2C19 [estimated prevalence of 17% and 18%, respectively based on literature review (36)] will be excluded since this could impact assessment of effects of cannabidiol.
  • Patients with abnormal baseline liver transaminases (any value above UNL), since up to 3-fold, dose-related elevations of liver transaminases (ALT and/or AST) occur in 13% of treated patients (vs. 1% placebo).
  • Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX.
  • Concomitant use of valproate, CNS depressants and alcohol, other hepatotoxic drugs.
  • The subject has HbA1c > 12%.
  • The subject is unable to withdraw any of the following medications listed below 48 hours prior to the study:
    • Drugs known to affect gastrointestinal transit or motor functions;
    • GLP-1 receptor or amylin agonists in patients with diabetes mellitus;
    • Drugs known to alter NI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics;
    • Serotonin and norepinephrine reuptake inhibitors; venlafaxine, duloxetine, desvenlafaxine, milnacipran, levomilnacipran;
    • Analgesic drugs including opiates, nonsteroidal, antiinflamatories, cyclooxygenase-2 inhibitors;
    • Antidiabetic treatment with pramlintide or glucagonlike peptide-1 receptor agonists;
    • N-methyl-d aspartate receptor antagonist. Phencyclidine, ketamine, tilemine, methadone, dextropropoxyphene, tramadol, ketobemidone;
    • 5-HT , 5hT 3, 5HT 4 agonist, or antagonist.
  • The subject has participated in another interventional clinical study within the past two weeks.
  • History of recent surgery (within 60 days of screening).
  • The subject has a history diagnosis of post-surgical gastroparesis.
  • A subject who, in the determination of the investigator, possesses any condition that the investigator believes would put the subject at risk or would preclude the subject from successfully completing all aspects of the study.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Daniel Maselli, M.D.

Open for enrollment

Contact information:

Kayla Arndt

(507)538-6599

Arndt.Kayla@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20460828

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