Pain, Opioids and Pro-Inflammatory Immune Responses

NCT01210066 | Terminated Phase 1 DMC

• 1 other identifier: 5R21DA027558
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Providing pain management to the patient who abuses prescription opioids presents a clinical challenge, not only due to concerns about "drug-seeking", but because they have increased sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to examine the role of opioid-induced proinflammatory changes in these responses.

Conditions

Pro-inflammatory Activity; Immunologic Activity Alteration

Keywords

inflammation; opioid-induced hyperalgesia; bupenorphine; prescription opioid abuse

Outcome Measures

Primary Outcomes (1)

• plasma levels of pro-inflammatory cytokine IL-6

  inflammatory cytokine activity will be evaluated with an in vivo approach over a three hour period of time to enable observation of the duration of opioid activity

  15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,

Study Arms (3)

Pain Challenge

ACTIVE COMPARATOR

Cold pressor test

Other: Cold pressor test

Pain + Opioid Challenge

ACTIVE COMPARATOR

IV fentanyl 1mcg/kg followed by cold pressor test

Other: Fentanyl plus cold pressor test

Opioid Challenge

ACTIVE COMPARATOR

Administration of fentanyl 1mcg/kg of subject weight

Drug: Fentanyl

Interventions

Fentanyl DRUG

IV fentanyl 1mcg/kg

Also known as: opioid

Opioid Challenge

Cold pressor test OTHER

Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes

Also known as: cold pressor task

Pain Challenge

Fentanyl plus cold pressor test OTHER

fentanyl IV 1mcg/kg fifteen minutes prior to cold pressor test (arm submerged in ice water until no longer tolerable but no longer than 5 minutes)

Also known as: opioid and cold pressor

Pain + Opioid Challenge

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male and non-pregnant female, non-smoking adults in good general health
• between the ages of 21-40 years old
• fluent in English with willingness to participate in the research study
• DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
• compliance in treatment and on a stable dose of buprenorphine (6-24mg/day) x at least 10 days prior to screening
• Participation in an ISAP treatment program or a qualified community-based opioid treatment program or private clinic for the entire duration of their study participation

You may not qualify if:

• regular use of any medication that influences immune status or immune system function
• regular use of a medication that influences pain perception, including opioids (\* only for healthy subjects population\*)
• Regular use of a medication that influences pain perception, except for buprenorphine (\*\* only for POA population\*\*)
• known hypersensitivity to opioids or no previous opioid exposure (\*only healthy controls)
• presence of acute or chronic pain syndrome
• neuropsychiatric illness (i.e., peripheral neuropathy, schizophrenia) known to affect pain perception
• presence of chronic immune compromise (hepatitis C, HIV) or acute infection within the last four weeks
• current or past history of high blood pressure, heart disease, or stroke, or currently have a pacemaker.
• current DSM-IV diagnosis
• BMI less than 18.5 or greater than 29.9
• History of sleep apnea

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Nursing

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Compton P, Griffis C, Breen EC, Torrington M, Sadakane R, Tefera E, Irwin MR. Opioid treatment of experimental pain activates nuclear factor-kappaB. J Opioid Manag. 2015 Mar-Apr;11(2):115-25. doi: 10.5055/jom.2015.0261.

  PMID: 25901477 RESULT

MeSH Terms

Conditions

Inflammation; Opioid-Related Disorders

Interventions

Fentanyl; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Peggy A Compton, RN PhD FAAN

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 28, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (1)