Opium Tincture Against Chronic Diarrhea - Healthy

Last updated: January 27, 2023
Sponsor: Asbjørn Mohr Drewes
Overall Status: Completed

Phase

N/A

Condition

Chronic Diarrhea

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT05702190
Dropizol_healthy
2020-004875-41
  • Ages > 20
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, arecapable of following instructions, can attend when needed, and are expected tocomplete the study.
  • The investigator will ensure that fertile female participants have a negativepregnancy test before each treatment visit and use contraception during the entity ofthe study.
  • Opioid naïve (in this study "opioid naïve" is defined as a person who does not have ahistory of opioid use/addiction. If the opioids were used more than five years beforethe start of experiment as an analgesic to treat pain post-surgery etc., this personwill be considered opioid naïve. If the person has never used opioids to treat painbut has participated in pain studies where opioids were given more than a year beforethis experiment, this person will be considered opioid naïve)
  • Healthy (assessed by a study-affiliated medical doctor)

Exclusion

Exclusion Criteria:

  • Known allergy towards pharmaceutical compounds similar to Dropizol.
  • Participation in other studies within 14 days of first visit (1 year if opioidsinvolved).
  • Expected need of medical/surgical treatment during the study
  • History of psychiatric illness (e.g. mental retardation, schizophrenia, affectivedisorders (depression), personality disorders or treatment with psychoactivemedications)
  • 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 ongoingexacerbation)
  • Known cor pulmonale
  • Female participants that are lactating
  • Medicine known to affect gastrointestinal motility must not be initiated during theentity of the study
  • Use of any analgesic medication within 48 hours before start as well as for theduration 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 theduration of the study.

Study Design

Total Participants: 20
Study Start date:
March 09, 2021
Estimated Completion Date:
June 01, 2022

Study 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.

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

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