An interventional study of Opium tincture and Placebo in Chronic Diarrhea, sponsored by Asbjørn Mohr Drewes. Completed at 1 site in Denmark. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Asbjørn Mohr Drewes · Not applicable, Interventional, and Other
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.
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.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 20 is below the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Asbjørn Mohr Drewes is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of opium tincture (Dropizol)
Drug: Opium tincture
Administration of placebo (identical to opium tincture in taste and appearance)
Drug: Placebo
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
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.
Gastrointestinal transit
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Time frame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)
Colonic motility patterns
Number of motility patterns in the colon measured by the 3D Transit Capsule
Time frame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)
Bowel movement frequency
Number of spontaneous bowel movements per day
Time frame: From day 1 to day 9
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea))
Time frame: From day 1 to day 9
Pupil diameter
Measured in mm
Time frame: Day 1, 6, and 9
General cognition
Evaluated using the Mini-Mental State Examination
Time frame: Day 1, 6, and 9
Reaction time
Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
Time frame: Day 1, 6, and 9
Short-term memory
Measured as number of digits correctly remembered after visual presentation
Time frame: Day 1, 6, and 9
Gastrointestinal symptoms
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire (ranging from 0 (no discomfort) to 6 (very severe discomfort)
Time frame: Day 1-9
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire (ranging from 0 (symptom absent) to 4 (very severe).
Time frame: Day 1-9
Electroencephalography spectral analysis
40 electrodes will be used to record EEG during a period of 5 minutes rest. The results will be used to model connectivity between brain centres as well as the dominating centres of brain. EEG power will be assessed in the Delta, Theta, Alpha, Beta, and Gamma bands between 1 and 70 Hertz. Finally inverse modelling will be conducted to explore the dominating centres of brain activity.
Time frame: Day 1 and 9
Pain tolerance threshold
Pressure will be applied to the tibial bone and the quadriceps muscle by a handheld pressure algometer. The pain tolerance threshold (measured in kPa) is reached when the participant reports the pain to be intolerable
Time frame: Day 1 and 9
Conditioned pain modulation
The left hand of the participant is immersed in 2.0 degree (celsius) cold water for up to 2 minutes or until the pain becomes intolerable. The participant is asked to rate the pain on a 10-point Visual Analogue Scale (0 being no pain and 10 being worst imaginable pain) every 10 seconds during the test.
Time frame: Day 1 and 9
Gastric half emptying time
Analysis of gastric half emptying time after ingestion of a standardized meal measured by MRI
Time frame: Day 1 and 9
Gastric contraction assessment
Analysis of gastric contraction including amplitude and frequency of contractions after ingestion of a standardized meal measured by MRI
Time frame: Day 1 and 9
Small bowel motility assessment
Analysis of small bowel motility after ingestion of a standardized meal measured using dynamic MRI images. A semi-automated analysis software enables registration of small bowel motility with the calculation of regional motility maps and quantification of motility indices.
Time frame: Day 1 and 9
Small bowel water content
Analysis of small bowel water content measured using heavily T2-weighted MRI images
Time frame: Day 1 and 9
Colon volume
Volumetric quantification of the colon measured using T2-weighted MRI images
Time frame: Day 1 and 9
Estimated gastrointestinal transit time
Using DIXON images, location of three capsules filled with contrast fluid ingested 24 hours before MRI scan
Time frame: Day 1 and 9
Plan to share: Yes — Data can by provided upon request
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Asbjørn Mohr Drewes