Prescription Opioid Effects in Abusers Versus Non-Abusers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00158184
First received: September 8, 2005
Last updated: January 24, 2012
Last verified: December 2011

September 8, 2005
January 24, 2012
June 2004
June 2009   (final data collection date for primary outcome measure)
Progressive ratio breakpoint value [ Time Frame: Post-drug ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00158184 on ClinicalTrials.gov Archive Site
Not Provided
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Prescription Opioid Effects in Abusers Versus Non-Abusers
Prescription Opioid Effects in Drug and Non-drug Abusers - 1

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Opioid-Related Disorders
  • Substance-Related Disorders
Drug: oxycodone
Placebo, 15 mg/70 kg oxycodone, and 30 mg/70 kg oxycodone are administered once per day
Other Name: immediate-release oxycodone
Experimental: Experimental
Placebo and active drug are administered during the study
Intervention: Drug: oxycodone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158184
#4691, R01DA016759-01, R01 DA16759-01, DPMC
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Sandra Comer, PhD New York State Psychiatric Institute
New York State Psychiatric Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP