Prescription Opioid Effects in Abusers Versus Non-Abusers
The purpose of this study is to examine the abuse liability of oxycodone and codeine in individuals with, and without, a history of prescription opioid abuse. The subjective and reinforcing effects of each drug will also be examined in the presence, and absence, of experimentally induced pain.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Prescription Opioid Effects in Drug and Non-drug Abusers - 1|
- Progressive ratio breakpoint value [ Time Frame: Post-drug ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Placebo and active drug are administered during the study
Placebo, 15 mg/70 kg oxycodone, and 30 mg/70 kg oxycodone are administered once per day
Other Name: immediate-release oxycodone
Prescription opioid abuse is becoming an increasingly widespread and serious public health concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintupled since 1984. Despite this trend, little experimental research has been directed towards understanding who may be abusing these medications, and under what conditions. The grant will examine the reinforcing, subjective, performance, and physiological effects of two commonly prescribed opioid medications (oxycodone and codeine) in two separate studies. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers. Additionally, because it is not clear under what conditions these medications are used, the effects of oxycodone and codeine will be examined in the presence and absence of experimentally induced pain. The results of these studies will yield important information about who may be abusing prescription opioid medication, and will provide a better understanding of several important variables that may influence the propensity to abuse these medications.
The following two studies will be performed during the grant period: 1) a study to examine the abuse liability of oxycodone; and 2) a study to examine the abuse liability of codeine. Both studies will include two groups of participants: prescription opioid abusers and non-abusers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158184
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Sandra Comer, PhD||New York State Psychiatric Institute|