NCT05702190

Opium Tincture Against Chronic Diarrhea - Healthy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Asbjørn Mohr Drewes · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: 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 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.

Conditions

• Chronic Diarrhea

Interventions

Type	Name	Description
DRUG	Opium tincture	Self-administration of opium tincture (10 mg/ml) as 2x5 drops on day 1, 3x10 drops on days 2-8, and 1x10 drops on day 9 in each study period.
DRUG	Placebo	Self-administration of placebo as 2x5 drops on day 1, 3x10 drops on days 2-8, and 1x10 drops on day 9 in each study period.

Timeline

• Start date: 2021-03-09
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2023-01-27
• Last updated: 2023-01-30

Locations

1 site across 1 country: Denmark