The goal of this proposal is to address the growing problem of prescription opioid abuse by examining the effects of oxycodone in a laboratory setting in the presence of clinical pain and following significant pain relief following maintenance on the buprenorphine / naloxone combination (Bup/NX). Participants diagnosed with moderate pain initially will be admitted to hospital and transitioned from their baseline prescription opioid to a standing daily dose of Bup/NX. During the Bup/NX maintenance periods, participants will have the opportunity to self-administer oxycodone and subjective responses to oxycodone as well as analgesic, physiological and performance effects will be measured. In the second phase of this study, the same patients who participated in the inpatient phase will be followed on an outpatient basis while maintained on Bup/NX. Primary outcome variables during the outpatient phase will include percentage of negative urine toxicology samples for opioids and number of weeks in treatment. A major goal of this proposal is to determine which variables collected in the laboratory most reliably predict subsequent relapse to opioid abuse. In addition, the utility of Bup/NX in treating patients diagnosed with both chronic pain and substance abuse will be assessed. Despite the significant increase in prescription opioid abuse over the past 5-10 years, very few studies have systematically examined the issues surrounding prescription opioid abuse in the population of individuals with chronic pain. To our knowledge, no studies to date have examined opioid self-administration in persons with pain who have a history of opioid abuse. Specifically, the current proposal aims to 1) characterize the behavioral effects of oxycodone in Bup/NX-maintained pain patients who are currently abusing their prescription opioids;and 2) examine the relationship between behavioral effects of oxycodone as measured in the laboratory setting, and subsequent relapse to opioid abuse. These studies will provide important information about prescription opioid abuse liability in pain patients and will yield a laboratory model for predicting likelihood to relapse to prescription opioid abuse. These questions are of immediate clinical relevance to the treatment of chronic pain with opioid therapy.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA020448-05
Application #
7794863
Study Section
Special Emphasis Panel (ZDA1-RXL-E (15))
Program Officer
Lin, Yu
Project Start
2005-09-25
Project End
2012-02-28
Budget Start
2010-03-01
Budget End
2012-02-28
Support Year
5
Fiscal Year
2010
Total Cost
$421,652
Indirect Cost
Name
New York State Psychiatric Institute
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032
Manubay, Jeanne; Davidson, Jesse; Vosburg, Suzanne et al. (2015) Sex differences among opioid-abusing patients with chronic pain in a clinical trial. J Addict Med 9:46-52
Roux, Perrine; Sullivan, Maria A; Cohen, Julien et al. (2013) Buprenorphine/naloxone as a promising therapeutic option for opioid abusing patients with chronic pain: reduction of pain, opioid withdrawal symptoms, and abuse liability of oral oxycodone. Pain 154:1442-8
Jones, Jermaine D; Sullivan, Maria A; Manubay, Jeanne et al. (2011) The subjective, reinforcing, and analgesic effects of oxycodone in patients with chronic, non-malignant pain who are maintained on sublingual buprenorphine/naloxone. Neuropsychopharmacology 36:411-22
Manubay, Jeanne M; Muchow, Carrie; Sullivan, Maria A (2011) Prescription drug abuse: epidemiology, regulatory issues, chronic pain management with narcotic analgesics. Prim Care 38:71-90, vi
Covey, Lirio S; Manubay, Jeanne; Jiang, Huiping et al. (2008) Smoking cessation and inattention or hyperactivity/impulsivity: a post hoc analysis. Nicotine Tob Res 10:1717-25