Clinical trial NCT05702190: Opium Tincture Against Chronic Diarrhea - Healthy
Official title: Opium Tincture Against Chronic Diarrhea - Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diarrhea
Keywords: Diarrhea
Constipation
Gastrointestinal transit
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal transit
timeFrame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)
Secondary outcomes:
measure: Colonic motility patterns
timeFrame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)
measure: Bowel movement frequency
timeFrame: From day 1 to day 9
measure: Stool consistency
timeFrame: From day 1 to day 9
measure: Pupil diameter
timeFrame: Day 1, 6, and 9
measure: General cognition
timeFrame: Day 1, 6, and 9
measure: Reaction time
timeFrame: Day 1, 6, and 9
measure: Short-term memory
timeFrame: Day 1, 6, and 9
measure: Gastrointestinal symptoms
timeFrame: Day 1-9
measure: Constipation symptoms
timeFrame: Day 1-9
measure: Electroencephalography spectral analysis
timeFrame: Day 1 and 9
measure: Pain tolerance threshold
timeFrame: Day 1 and 9
measure: Conditioned pain modulation
timeFrame: Day 1 and 9
measure: Gastric half emptying time
timeFrame: Day 1 and 9
measure: Gastric contraction assessment
timeFrame: Day 1 and 9
measure: Small bowel motility assessment
timeFrame: Day 1 and 9
measure: Small bowel water content
timeFrame: Day 1 and 9
measure: Colon volume
timeFrame: Day 1 and 9
measure: Estimated gastrointestinal transit time
timeFrame: Day 1 and 9
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Asbjørn Mohr Drewes
role: PRINCIPAL_INVESTIGATOR
References: