Effect of Opioids on Experimental Hyperalgesia in Oesophagus, Skin and Muscles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-03-31

Brief Summary

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The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Detailed Description

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The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids, Oxycodone and Morphine will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin by capsaicin and in oesophagus by a mixture of capsaicin and acid, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Conditions

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Pain

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 65 years
* Signed informed concent
* Healthy
* Women must use a safe contraceptive method
* Negative pregnancy test

Exclusion Criteria

* Pregnancy
* Allergy to study medication
* Participating in another medicine study
* Previous addictive behaviour
* Need for other treatments
* Use of strong analgesics
* Use of any analgesics 24 hours before the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Gastroenterological Outpatients Clinic, Aalborg Hospital, Aalborg

Principal Investigators

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Asbjørn Mohr Drewes, Professor

Role: PRINCIPAL_INVESTIGATOR

Aalborg Hospital S. Gastroenterological Outpatients clinic

Locations

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Gastroenterological outpatients clinic

Aalborg, Aalborg, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2007-001881-33

Identifier Type: -

Identifier Source: org_study_id