Prescription Opioid Effects in Abusers Versus Non-Abusers

Phase 2

Completed

Interventions: Drug: oxycodone 15 mg
Drug: oxycodone 30 mg
Drug: Placebo 0 mg

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.

Recruitment & Eligibility

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:
1. Current or lifetime history of substance abuse or dependence according to DSM-IV criteria (those requiring detoxification)
2. Consumes more than 500 mg caffeine daily
3. Seeking treatment for substance use

Arm && Interventions

Group	Intervention	Description
Rx Opioid Abusers	oxycodone 15 mg	Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
Rx Opioid Non-Abusers	oxycodone 30 mg	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.
Rx Opioid Non-Abusers	oxycodone 15 mg	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.
Rx Opioid Abusers	Placebo 0 mg	Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
Rx Opioid Non-Abusers	Placebo 0 mg	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.
Rx Opioid Abusers	oxycodone 30 mg	Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.

Primary Outcome Measures

Name	Time	Method
Breakpoint	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	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.

Secondary Outcome Measures

Name	Time	Method
Drug Liking	Highest rating obtained following adminstration of each of the 3 test doses.	Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."