Prescription Opioid Effects in Abusers Versus Non-Abusers - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00158184

Purpose

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.

Condition	Intervention	Phase
Opioid-Related Disorders Substance-Related Disorders	Drug: oxycodone	Phase II

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Drug Abuse

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

Progressive ratio breakpoint value [ Time Frame: Post-drug ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	June 2004
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental Placebo and active drug are administered during the study	Drug: oxycodone Placebo, 15 mg/70 kg oxycodone, and 30 mg/70 kg oxycodone are administered once per day Other Name: immediate-release oxycodone

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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:
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158184

Locations

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Sandra Comer, PhD

New York State Psychiatric Institute

More Information

No publications provided

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00158184 History of Changes
Other Study ID Numbers:	#4691, R01DA016759-01, R01 DA16759-01, DPMC
Study First Received:	September 8, 2005
Last Updated:	January 24, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012