Prescription Opioid Effects in Abusers Versus Non-Abusers

New York State Psychiatric Institute27 enrolled

Overview

The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Interventions

oxycodone 15 mgDRUG

15 mg/70 kg oxycodone administered once per day, orally.

oxycodone 30 mgDRUG

30 mg/70 kg oxycodone administered once per day, orally.

Placebo 0 mgDRUG

0 mg placebo dose administered once a day, orally.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

Drug Liking

Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."

Time frame: Highest rating obtained following adminstration of each of the 3 test doses.

Data from ClinicalTrials.gov

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