Pain, Opioids and Pro-Inflammatory Immune Responses

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Analgesics, Opioid; Fentanyl; Vasoconstrictor Agents

Criteria

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