NCT05702190
Completed
Not Applicable
Opium Tincture Against Chronic Diarrhea - Healthy
Asbjørn Mohr Drewes1 site in 1 country20 target enrollmentStarted: March 9, 2021Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asbjørn Mohr Drewes
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Gastrointestinal transit
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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)
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, 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
Arms & Interventions
Opium tincture
Active Comparator
Administration of opium tincture (Dropizol)
Intervention: Opium tincture (Drug)
Placebo
Placebo Comparator
Administration of placebo (identical to opium tincture in taste and appearance)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Gastrointestinal transit
Time Frame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Secondary Outcomes
- Short-term memory(Day 1, 6, and 9)
- Colonic motility patterns(Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after))
- Pupil diameter(Day 1, 6, and 9)
- Reaction time(Day 1, 6, and 9)
- Pain tolerance threshold(Day 1 and 9)
- Gastric half emptying time(Day 1 and 9)
- Bowel movement frequency(From day 1 to day 9)
- Stool consistency(From day 1 to day 9)
- General cognition(Day 1, 6, and 9)
- Gastrointestinal symptoms(Day 1-9)
- Gastric contraction assessment(Day 1 and 9)
- Small bowel motility assessment(Day 1 and 9)
- Colon volume(Day 1 and 9)
- Estimated gastrointestinal transit time(Day 1 and 9)
- Conditioned pain modulation(Day 1 and 9)
- Constipation symptoms(Day 1-9)
- Small bowel water content(Day 1 and 9)
- Electroencephalography spectral analysis(Day 1 and 9)
Investigators
Asbjørn Mohr Drewes
Professor
Aalborg University Hospital
Study Sites (1)
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