Chronic DiarrheaNCT05702190
Opium Tincture Against Chronic Diarrhea - Healthy
A study testing Opium tincture in people with Chronic Diarrhea, run by Asbjørn Mohr Drewes at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Diarrhea
- What is being tested?
- Opium tincture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Mar 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
- Female participants that are lactating
- Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
- Use of any analgesic medication within 48 hours before start as well as for the duration of the study (urine drug test will be performed prior to treatment start).
- Intake of alcohol within 48 hours before start of study period as well as for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Opium tincture, Placebo
- Keywords
- Diarrhea, Constipation, Gastrointestinal transit
- Medical subject headings
- Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opium tinctureDrug
Also called Dropizol
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Opium tincture | Active comparator | Administration of opium tincture (Dropizol) Receives: Drug: Opium tincture |
| Placebo | Placebo comparator | Administration of placebo (identical to opium tincture in taste and appearance) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Measured: 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
Number of motility patterns in the colon measured by the 3D Transit Capsule
Measured: 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
Measured: From day 1 to day 9
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea))
Measured: From day 1 to day 9
Pupil diameter
Measured in mm
Measured: Day 1, 6, and 9
General cognition
Evaluated using the Mini-Mental State Examination
Measured: Day 1, 6, and 9
Reaction time
Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
Measured: Day 1, 6, and 9
Short-term memory
Measured as number of digits correctly remembered after visual presentation
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 1 and 9
Gastric half emptying time
Analysis of gastric half emptying time after ingestion of a standardized meal measured by MRI
Measured: 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
Measured: 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.
Measured: Day 1 and 9
Small bowel water content
Analysis of small bowel water content measured using heavily T2-weighted MRI images
Measured: Day 1 and 9
Colon volume
Volumetric quantification of the colon measured using T2-weighted MRI images
Measured: 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
Measured: Day 1 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start9 Mar 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asbjørn Mohr Drewes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asbjørn Mohr Drewes, Aalborg University Hospital
- Investigators
- Asbjørn Mohr Drewes, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702190
- Sponsor's protocol ID
- Dropizol_healthy
- Other IDs
- 2020-004875-41
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can by provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opium Tincture Against Chronic Diarrhea - Healthy
- ClinicalTrials.gov ID
- NCT05702190
- Acronym / sponsor ID
- Dropizol_healthy
- Conditions
- Chronic Diarrhea
- Keywords
- Diarrhea, Constipation, Gastrointestinal transit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asbjørn Mohr DrewesUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opium tincture | Active comparator | Drug: Opium tinctureAdministration of opium tincture (Dropizol) |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo (identical to opium tincture in taste and appearance) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opium tinctureAlso: DropizolSelf-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 | Opium tincture |
| PlaceboSelf-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. | Drug | Placebo |
Primary outcome
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
18 secondary outcomes
Colonic motility patterns
Time frame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)
Bowel movement frequency
Time frame: From day 1 to day 9
Stool consistency
Time frame: From day 1 to day 9
Pupil diameter
Time frame: Day 1, 6, and 9
General cognition
Time frame: Day 1, 6, and 9
Reaction time
Time frame: Day 1, 6, and 9
Short-term memory
Time frame: Day 1, 6, and 9
Gastrointestinal symptoms
Time frame: Day 1-9
Constipation symptoms
Time frame: Day 1-9
Electroencephalography spectral analysis
Time frame: Day 1 and 9
Pain tolerance threshold
Time frame: Day 1 and 9
Conditioned pain modulation
Time frame: Day 1 and 9
Gastric half emptying time
Time frame: Day 1 and 9
Gastric contraction assessment
Time frame: Day 1 and 9
Small bowel motility assessment
Time frame: Day 1 and 9
Small bowel water content
Time frame: Day 1 and 9
Colon volume
Time frame: Day 1 and 9
Estimated gastrointestinal transit time
Time frame: Day 1 and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Yes. Data can by provided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asbjørn Mohr Drewes principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opium tincture in people with Chronic Diarrhea, run by Asbjørn Mohr Drewes at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal transit (time frame: Measurement started on day 2 of each study period until expulsion of the capsule (typically 24-48 hours after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.