Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

NCT ID: NCT01749826

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-07-31

Brief Summary

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

Detailed 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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Chronic Opioid Exposure

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.

Group Type: EXPERIMENTAL

Morphine Sulfate

Intervention Type: DRUG

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.

Acute Opioid Exposure

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.

Group Type: EXPERIMENTAL

Morphine Sulfate

Intervention Type: DRUG

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.

Interventions

Morphine Sulfate

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.

Intervention Type: DRUG

Other Intervention Names

MS Contin; Morphine Sulfate ER; Roxanol; Kadian

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Larry Fu-nien Chu

Associate Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Larry Fu-nien Chu

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-10212009-4201

Identifier Type: -

Identifier Source: org_study_id