Opium tincture against chronic diarrhea - Healthy:An investigator initiated, randomized placebo-controlled, double-blinded, cross-over, clinical trial

Mech-Sense, Aalborg University Hospital0 sites20 target enrollmentStarted: October 12, 2020Last updated: November 15, 2021

Overview

No summary available.

•Signed informed consent before any study specific procedures
•Able to read and understand Danish
•Male or female with an age of 20 years or more
•The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study.
•The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study.
•Opioid naïve\*
•Healthy (assessed by a study\-affiliated medical doctor)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Known allergy towards pharmaceutical compounds similar to Dropizol.
•Participation in other studies within 14 days of first visit (1 year if opioids involved).
•Expected need of medical/surgical treatment during the study
•History of psychiatric illness (e.g. mental retardation, schizophrenia, affective disorders (depression), personality disorders or treatment with psychoactive medications)
•History of substance abuse (e.g. alcohol, nicotine, THC, benzodiazepine, central stimulants and/or opioids)
•Family history of substance abuse
•Increased intracranial pressure
•Known major stenosis of the intestines
•Planned MRI within the next 3 months
•Metal implants or pacemaker

Sponsor

Mech-Sense, Aalborg University Hospital