Status:
COMPLETED
Morphine Modulation of The Brain's Pain Matrix
Lead Sponsor:
University of Aarhus
Conditions:
Pain
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief Summary
The aim of the current project is to use a model of painful stimulation of skin, muscles and internal organs, where it is possible to measure activity in the brain centers that process pain simultaneo...
Detailed Description
The tests will consist of one main study (I) and one sub-study (i): I) Experiments in the painlaboratory in the gastroenterology clinic, where 40 healthy subjects will be examined with different pain...
Eligibility Criteria
Inclusion
- Signed and dated "Written informed consent"
- Age between 20 and 65.
- Caucasian
- That it is in the researcher's belief that the subject fully understand the contents of the study and is willing and able to comply with instructions, have the opportunity to meet with visitors, and is expected to complete the entire study. Further, it is in the researcher's beliefs (by which demanded strict action to exclusion criterion 4 and 5) that subjects with abusive tendencies are not included .
- The person must be healthy ie. without previous chronic or recurrent pain rewarding diseases. Including the person must have:
- a blood pressure is 140/90 or less. If not satisfied, a medical assessment to determine whether the person is still included, albeit with a comment and reasons recorded in the CRF.
- a resting heart rate of at least 45 bpm. minute (measured after 5 minutes of recumbent rest). If not satisfied, a medical assessment to determine whether the person is still included, albeit with a comment and reasons recorded in the CRF.
- That women use safe contraceptive methods as the pill, coil, depot injection of progestin subdermal implantation, hormonal vaginal ring and transdermal patch.
- Negative pregnancy test prior to the conclusion of the experiment
Exclusion
- Pregnancy.
- Known allergy to study medication
- Current or previous participation in another drug trial within 30 days before screening.
- Former participation in trials when given morphine or morphine-like substances.
- Former addiction behaviors defined as abuse of alcohol, marijuana, opiates or other narcotics or family members who have been / are a drug addict.
- Earlier pain rewarding or mental illness.
- Expected need for medical treatment, surgery or hospitalization during the study
- Concomitant use of strong pain medications
- Use of any analgesics 24 hours before each test.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01245244
Start Date
October 1 2010
End Date
September 1 2012
Last Update
September 21 2012
Active Locations (1)
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1
Department of Gastroenterology, Aalborg Hospital
Aalborg, Denmark, 9000