Opium Tincture Against Chronic Diarrhea - Healthy

NCT05702190 | Completed DMC

• 2 other identifiers: Dropizol_healthy2020-004875-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Diarrhea

Keywords

Diarrhea; Constipation; Gastrointestinal transit

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal transit

  Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment

  Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)

Secondary Outcomes (18)

• Colonic motility patterns

  Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)

• Bowel movement frequency

  From day 1 to day 9

• Stool consistency

  From day 1 to day 9

• Pupil diameter

  Day 1, 6, and 9

• General cognition

  Day 1, 6, and 9

Study Arms (2)

Opium tincture

ACTIVE COMPARATOR

Administration of opium tincture (Dropizol)

Drug: Opium tincture

Placebo

PLACEBO COMPARATOR

Administration of placebo (identical to opium tincture in taste and appearance)

Drug: Placebo

Interventions

Opium tincture DRUG

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.

Also known as: Dropizol

Opium tincture

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Asbjørn Mohr Drewes: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Diarrhea; Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asbjørn Mohr Drewes

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 27, 2023
• Study Start: March 9, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Researchers who provide a methodological sound proposal

Locations

DK (1)