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Prescription Opioid Effects in Abusers Versus Non-Abusers
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), July 2008
First Received: September 8, 2005   Last Updated: July 22, 2008   History of Changes
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
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

Drug Information available for: Oxycodone Oxycodone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title: Prescription Opioid Effects in Drug and Non-Drug Abusers - 1

Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Estimated Enrollment: 96
Study Start Date: June 2004
Estimated Study Completion Date: June 2009
Estimated 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

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

Contacts
Contact: Sandra Comer, PhD 212-543-5981

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: James Mckay, PhD     212-543-5981     sdc10@columbia.edu    
Sponsors and Collaborators
Investigators
Principal Investigator: Sandra Comer, PhD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute and Columbia University ( Sandra D. Comer, PhD )
Study ID Numbers: NIDA-16759-1, R01-16759-1, DPMC
Study First Received: September 8, 2005
Last Updated: July 22, 2008
ClinicalTrials.gov Identifier: NCT00158184     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Mental Disorders
Oxycodone
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid

Additional relevant MeSH terms:
Disease
Oxycodone
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Pathologic Processes
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 06, 2009