Last updated: April 24, 2024
Sponsor: Asbjørn Mohr Drewes
Overall Status: Completed
Phase
2
Condition
Ulcers
Gastrointestinal Diseases And Disorders
Constipation
Treatment
Placebo
Tramadol
Clinical Study ID
NCT06385561
Tramadol_OIBD
2022-500108-23-00
Ages 20-40 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 drugmetabolism).
- The researcher believes that the participant understands the study details, iscompliant and is expected to complete the study.
- Opioid naïve* (who have not taken prescription opioid for one week or longer and atleast a year have passed since completion of a previous opioid study.)
- Between 20 and 40 years of age.
- A State Trait Anxiety Inventory (STAI) score in the range of 20-37 i.e., classified as "no or low anxiety" at inclusion.
Exclusion
Exclusion Criteria:
- Known hypersensitivity or allergy towards the used pharmaceutical compounds orpharmaceutical compounds similar to those used in 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 (includingall 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 liverfunction, gastrointestinal obstruction or perforation, acute surgical abdominalcomplications such as appendicitis, Mb. Crohn's, ulcerative colitis, and toxic megacolon).
- History of substance abuse (alcohol, tetrahydrocannabinol (THC), benzodiazepine,central stimulants and/or opioids, urine drug test will be performed prior totreatment start). ¹
- History of major mental disorders (e.g., major anxiety, major depression or treatmentwith psychoactive medications etc.) ²
- Metal implants or pacemaker.
- Daily use of prescription only medicine
- Daily alcohol consumption
- Participation motivated by "wrongful" reasons such as poor economy, or psychosocialissues e.g., problems in the family, loneliness, sadness. People with such problemsmay be more likely to develop substance dependence.1
- Intake of alcohol within 48 hours before start of study period or any alcoholconsumption during each study period. If consumption takes place during the study theparticipant will be excluded.
- Use of any analgesic medication within 48 hours before start as well as for theduration of the study. If consumption takes place during the study the participantwill be excluded.
- Nicotine use
Study Design
Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 11, 2022
Estimated Completion Date:
May 15, 2023
Connect with a study center
Aalborg University Hospital
Aalborg, 9000
DenmarkSite Not Available

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