Opium Tincture Against Chronic Diarrhea - Healthy

Asbjørn Mohr Drewes

Status

Completed

Conditions

Chronic Diarrhea

Treatments

Drug: Placebo

Drug: Opium tincture

Study type

Interventional

Funder types

Other

Identifiers

NCT05702190

2020-004875-41 (EudraCT Number)

Dropizol_healthy

Details and patient eligibility

About

The purpose of this study is to investigate the mechanistic anti-propulsive effects of opium tincture on the gastrointestinal tract of a cohort of healthy participants.

Full description

Opium tincture is used a symptomatic drug against chronic diarrhea even though no clinical studies have investigated the effect on gastrointestinal function. With this randomized, double-blind, placebo-controlled cross-over trial in 20 healthy participants, the investigators wish to provide evidence-based insights into the effects of opium tincture on gastrointestinal function. Additionally, effects on the central nervous system will be investigated a tertiary aim.

Enrollment

20 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 (in this study "opioid naïve" is defined as a person who does not have a history of opioid use/addiction. If the opioids were used more than five years before the start of experiment as an analgesic to treat pain post-surgery etc., this person will be considered opioid naïve. If the person has never used opioids to treat pain but has participated in pain studies where opioids were given more than a year before this experiment, this person will be considered opioid naïve)
Healthy (assessed by a study-affiliated medical doctor)

Exclusion criteria

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, tetrahydrocannabinol (THC), benzodiazepine, central stimulants and/or opioids)
Family history of substance abuse
Known increased intracranial pressure
Known major stenosis of the intestines
Planned MRI within the next 3 months
Metal implants or pacemaker
Known severe decreased renal function (defined as estimated glomerular filtration rate (eGFR) below 45)
Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
Treatment with Monoamine oxidase (MAO) inhibitors during the entity of the study
Known severe chronic obstructive pulmonary disease (COPD) or acute severe asthma (defined as forced expiratory volume in 1 second (FEV1) below 50 % or acute ongoing exacerbation)
Known cor pulmonale
Female participants that are lactating
Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
Use of any analgesic medication within 48 hours before start as well as for the duration of the study (urine drug test will be performed prior to treatment start).
Intake of alcohol within 48 hours before start of study period as well as for the duration of the study.