Prescription Opioid Effects in Abusers Versus Non-Abusers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.

Detailed Description
-----------------
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 study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.

Official Title
-----------------
Prescription Opioid Effects in Drug and Non-drug Abusers - 1

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: oxycodone 15 mg
* Drug: oxycodone 30 mg
* Drug: Placebo 0 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In good physical health Women reporting regular menstrual cycles lasting between 24 to 35 days Able to perform study procedures Normal body weight Use of opioids for medical purposes (cough, pain, or diarrhea) or recreational purposes at least twice in lifetime with no serious adverse effects Current opioid abuse, but not opioid dependence (drug abusers only) Exclusion Criteria: On parole or probation Recently convicted of a crime of violence History of significant violent behavior Current Axis I psychopathology Significant Axis II disorder Pregnancy Women who have irregular menstrual cycles, or who are dysmenorrheic, amenorrheic, or menopausal Women who have been pregnant or breastfeeding within the past 6 months Women who have had a miscarriage or abortion within the past 6 months Women who meet DSM-IV criteria for premenstrual dysphoric disorder Women who report suffering from moderate to severe premenstrual symptoms Women seeking treatment for premenstrual problems Taking prescription or over-the-counter psychotropic medication History of chronic pain, or routinely uses over-the-counter analgesics (more than 4 days per month) Blood pressure greater than 150/90 mm Hg Reports of sensitivity, allergy, or contraindication to opioids Non-drug abusers: Current or lifetime history of substance abuse or dependence according to DSM-IV criteria (those requiring detoxification) Consumes more than 500 mg caffeine daily Seeking treatment for substance use

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rx Opioid Abusers<br>Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random. | Drug: oxycodone 15 mg<br>* 15 mg/70 kg oxycodone administered once per day, orally.<br>* Other names: immediate-release oxycodone;Drug: oxycodone 30 mg<br>* 30 mg/70 kg oxycodone administered once per day, orally.<br>* Other names: immediate-release oxycodone;Drug: Placebo 0 mg<br>* 0 mg placebo dose administered once a day, orally.<br>* Other names: 0 mg;|
| Active Comparator: Rx Opioid Non-Abusers<br>Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random. | Drug: oxycodone 15 mg<br>* 15 mg/70 kg oxycodone administered once per day, orally.<br>* Other names: immediate-release oxycodone;Drug: oxycodone 30 mg<br>* 30 mg/70 kg oxycodone administered once per day, orally.<br>* Other names: immediate-release oxycodone;Drug: Placebo 0 mg<br>* 0 mg placebo dose administered once a day, orally.<br>* Other names: 0 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breakpoint | Maximum number of finger presses on a computer mouse completed. The Breakpoint is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability. | Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Liking | Subjective rating of drug Liking on a scale of 0 to 100. Greater numbers indicate greater subjective report of Liking. | Highest rating obtained following adminstration of each of the 3 test doses. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opiate, Opioid, Abuse Liability, Abuse Potential