Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

NCT01749826 | Terminated Results

• 1 other identifier: SU-10212009-4201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammation

Keywords

Inflammation, opioids, immune system

Outcome Measures

Primary Outcomes (1)

• Changes in Cytokine Release

  5 CCs of blood are drawn on day 1 and day 30.

  Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30

Secondary Outcomes (3)

• Laser Doppler Images

  Changes in laser doppler images are measured between images taken on Day 1 and Day 30

• Peltier Device-Heat Pain

  Differences in heat pain are assessed between measurements taken on Day 1 and Day 30

• Mechanical Pain Stimuli

  Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30

Study Arms (2)

Chronic Opioid Exposure

EXPERIMENTAL

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.

Drug: Morphine Sulfate

Acute Opioid Exposure

EXPERIMENTAL

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.

Drug: Morphine Sulfate

Interventions

Morphine Sulfate 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.

Also known as: MS Contin, Morphine Sulfate ER, Roxanol, Kadian

Acute Opioid Exposure; Chronic Opioid Exposure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Healthy volunteer
• Not allergic to remifentanil

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

We were unable to analyze any data.

Results Point of Contact

• Title: Dr. Larry F. Chu
• Organization: Stanford University School of Medicine Department of Anesthesiology

lchu@stanford.edu

6507236632

Study Officials

• Dr Larry Fu-nien Chu

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: December 17, 2012
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 30, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)