Study on Tramadol’s Effect on Opioid-Induced Bowel Dysfunction in Patients Using Opioids

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What is this study about?

This clinical trial is focused on studying a condition known as opioid-induced bowel dysfunction, which can occur when people use opioid medications. The study will explore how a medication called tramadol, which is a type of pain reliever, affects this condition. Participants in the study will receive either tramadol or a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to understand tramadol’s impact on the digestive system, specifically looking at how it affects the movement and function of the stomach and intestines. This includes examining how quickly food moves through the digestive tract, the patterns of movement in the intestines, and the volume and water content in the colon. The study will also assess any symptoms of constipation and other related digestive issues.

Participants will be involved in the study for a period of up to 10 days. During this time, various assessments will be conducted, including imaging tests like MRI to observe the digestive system. The study aims to provide valuable insights into how tramadol influences bowel function in individuals who have not previously used opioids extensively.

1 joining the study

Upon joining the study, you will be assessed by a study-affiliated medical doctor to confirm that you are healthy and meet the study’s criteria.

You will be required to sign an informed consent form, indicating that you understand the study and agree to participate.

2 initial assessment

You will undergo an initial assessment to ensure you meet all the inclusion criteria, such as being between 20 and 40 years of age, of Northern European descent, and opioid naïve.

Your anxiety levels will be evaluated using the STAI score, which should be in the range of 20-37, indicating no or low anxiety.

3 medication administration

You will receive the medication tramadol or a placebo tablet orally. The dosage, frequency, and duration of administration will be explained to you by the study team.

The aim is to determine tramadol’s ability to induce opioid-induced bowel dysfunction by exploring gastrointestinal transit, motility pattern, secretion, and colonic volume.

4 monitoring and assessments

Throughout the study, you will be monitored for changes in gastrointestinal transit time, both total and colorectal.

You will be asked to provide subjective assessments of constipation and opiate withdrawal using specific questionnaires like PAC-SYM, BSFS, GSRS, BFI, and SOWS.

5 imaging and diagnostic tests

You will undergo imaging tests such as MRI to assess colon volume, water content, gastric half emptying time, gastric accommodation, gastric motility, small bowel motility, and small bowel water content.

These tests will help evaluate segmental transit time of the stomach, small intestine, and colonic segments.

6 completion of the study

Upon completion of the study, you will have a final assessment to evaluate any changes or effects experienced during the trial.

The study team will provide you with any necessary follow-up instructions or information.

Who Can Join the Study?

Must be healthy, as determined by a doctor involved in the study.
Must have signed an informed consent, which means you agree to participate after understanding the study details.
Must be able to read and understand the Danish language.
Must be male to avoid the influence of menstrual cycles on the study results.
Must be of Northern European descent to reduce differences in how the body processes the drug.
The researcher must believe that you understand the study details, will follow the study rules, and are likely to complete the study.
Must be opioid naïve, meaning you have not taken prescription opioids for at least one week, and it has been at least a year since you participated in any previous opioid study.
Must be between 20 and 40 years of age.
Must have a STAI score between 20 and 37, which means you have no or low anxiety at the start of the study. STAI is a questionnaire that measures anxiety levels.

Who Cannot Join the Study?

Patients who are not male cannot participate in the study.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Mgnf Slufq	Aalborg	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	23.05.2022

Trial locations

Investigated drugs:

Tramadol

Tramadol is a medication used to relieve moderate to moderately severe pain. In this clinical trial, it is being studied to see how it affects bowel function, particularly when it is used alongside other opioid medications. Opioids can sometimes cause bowel problems, like constipation, and this study is looking at whether tramadol can influence these effects. The researchers are examining how tramadol affects the movement of the digestive system, the pattern of muscle contractions in the intestines, the amount of fluid secreted in the gut, and the size of the colon. This information will help understand if tramadol changes how the bowel works when opioids are used.

Investigated diseases:

Drug use disorder

Opioid-Induced Bowel Dysfunction – Opioid-induced bowel dysfunction is a condition that arises from the use of opioid medications, which can affect the normal functioning of the gastrointestinal tract. This condition is characterized by a range of symptoms, including reduced bowel movements, hard stools, and a sensation of incomplete evacuation. The opioids slow down the movement of the intestines, leading to increased water absorption and resulting in constipation. Over time, this can lead to discomfort, bloating, and abdominal pain. The dysfunction can also affect the motility patterns of the stomach and small intestine, altering the normal digestive process. Additionally, it may impact the secretion and volume of the colon, further complicating bowel movements.

Trial ID:

2022-500108-23-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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