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Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

Stanford University logo

Stanford University

Status

Terminated

Conditions

Inflammation

Treatments

Drug: Morphine Sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT01749826
SU-10212009-4201

Details and patient eligibility

About

We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

Full description

We are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. Preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. Translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-60 years old
  • Healthy volunteer
  • Not allergic to remifentanil

Exclusion criteria

  • Patients younger than 18 or older than 70
  • Patients unwilling or unable to follow study instructions
  • Patients who don't speak English
  • Patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as Advil or Naproxen during 2 weeks prior to and during the 1 month study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Chronic Opioid Exposure
Experimental group
Description:
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
Treatment:
Drug: Morphine Sulfate
Acute Opioid Exposure
Experimental group
Description:
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
Treatment:
Drug: Morphine Sulfate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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