Status:
TERMINATED
Pain, Opioids and Pro-Inflammatory Immune Responses
Lead Sponsor:
University of California, Los Angeles
Conditions:
Pro-inflammatory Activity
Immunologic Activity Alteration
Eligibility:
All Genders
21-40 years
Phase:
PHASE1
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 pa...
Detailed Description
Both acute pain and opioid administration have been shown to induce a systemic pro-inflammatory response. However, the presence of these inflammatory responses is unknown in situations where a co-occu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Supplementary Inclusion Criteria: Prescription Opioid Abusers
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01210066
Start Date
July 1 2010
End Date
May 1 2012
Last Update
December 29 2016
Active Locations (1)
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1
UCLA School of Nursing
Los Angeles, California, United States, 90095