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Tramadol OIBD
EU CTIS ID: 2022-500108-23-00
What this study is testing
The aim of this study is to determine tramadol´s ability to induce opioid induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Healthy (assessed by a study-affiliated medical doctor.)
- Signed informed consent.
- Able to read and understand Danish.
- Male (to avoid influence of menstrual cycles)
- Northern European descent (to minimize genetic variance influences on drug metabolism).
- The researcher believes that the participant understands the study details, is compliant and is expected to complete the study.
You likely can't join if
- Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
- History of substance abuse (alcohol, THC, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start).
- History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.)
- Metal implants or pacemaker.
- Daily use of prescription only medicine
- Use of nicotine
See the full eligibility criteria
- Healthy (assessed by a study-affiliated medical doctor.)
- Signed informed consent.
- Able to read and understand Danish.
- Male (to avoid influence of menstrual cycles)
- Northern European descent (to minimize genetic variance influences on drug metabolism).
- The researcher believes that the participant understands the study details, is compliant and is expected to complete the study.
- Opioid naïve (who have not taken prescription opioid for one week or longer and at least a year have passed since completion of a previous opioid study.)
- Between 20 and 40 years of age
- A STAI score in the range of 20-37 i.e., classified as “no or low anxiety” at inclusion.
- Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
- History of substance abuse (alcohol, THC, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start).
- History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.)
- Metal implants or pacemaker.
- Daily use of prescription only medicine
- Use of nicotine
- Daily alcohol consumption
- Participation motivated by “wrongful” reasons such as poor economy, or psychosocial issues e.g., problems in the family, loneliness, sadness. People with such problems may be more likely to develop substance dependence.
- Intake of alcohol within 48 hours before start of study period or any alcohol consumption during each study period.
- Use of any analgesic medication within 48 hours before start as well as for the duration of the study
- Less than three spontaneous bowel movements per week.
- Participation in other studies within 14 days prior to first visit.
- Expected need of medical/surgical treatment during the study.
- Any diagnosed disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn’s, ulcerative colitis, and toxic mega colon).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.