NCT05690321

Opium Tincture Against Chronic Diarrhea - Patients

Opium Tincture Against Chronic Diarrhea - Patients An Investigator Initiated, Randomized Placebo-controlled, Double-blinded, Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Asbjørn Mohr Drewes · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Diarrhea

Interventions

Type	Name	Description
DRUG	Opium tincture	Self-administration of opium tincture (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period
DRUG	Placebo	Self-administration of placebo (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period

Timeline

• Start date: 2022-11-17
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2023-01-19
• Last updated: 2024-04-22

Locations

2 sites across 1 country: Denmark