Opium Tincture Against Chronic Diarrhea - Patients

Phase 2

Completed

• Conditions: Chronic Diarrhea
• Interventions: Drug: Placebo; Drug: Opium tincture

• Registration Number: NCT05690321
• Lead Sponsor: Asbjørn Mohr Drewes

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 patients with chronic diarrhea

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 16 patients with chronic diarrhea, we 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.

Study Timeline

• Study Start: 2022-11-17
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.
  • Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed.

OR

• No specific underlying pathophysiology has been identified and treatment with loperamide has failed.
• At least 6 months post-surgery in the gastrointestinal tract
• No sign of cancer at standard clinical follow-up
• Chronic diarrhea defined as at least 3 daily bowel movements for the last week

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, major depression)
  • History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/or opioids)
  • Family history of substance abuse
  • Known major stenosis of the intestines
  • Known severe decreased renal function (defined as eGFR below 30)
  • Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
  • Treatment with MAO- inhibitors during the entity of the study
  • Severe COPD or acute severe asthma (defined as 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
  • Treatment with opium tincture during the last month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo treatment	Placebo	Administration of placebo (identical to opium tincture in taste and appearance)
Active treatment	Opium tincture	Administration of opium tincture (Dropizol)

Primary Outcome Measures

Name	Time	Method
Bowel movement frequency	From day 1 to 7	Difference in number of spontaneous bowel movements per day between arms

Secondary Outcome Measures

Name	Time	Method
General cognition	Day 1, 4 and 7 in each study period	Evaluated using the Mini-Mental State Examination
Gastrointestinal transit	Measurement started on day 4 of each study period until expulsion of the capsule]	Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment
Stool consistency	From day 1 to 7 in each study period	Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)
Pupil diameter	Day 1, 4 and 7 in each study period	Measured in mm
Reaction time	Day 1, 4 and 7 in each study period	Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
Constipation symptoms	Day 1, 4 and 7 in each study period	Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
Short-term memory	Day 1, 4 and 7 in each study period	Measured as number of digits correctly remembered after visual presentation
Gastrointestinal symptoms	Day 1, 4 and 7 in each study period	Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire

Trial Locations

Locations (2)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University hospital; 🇩🇰 Aarhus, Denmark