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Completed

NCT Number: NCT00158184

Prescription Opioid Effects in Abusers Versus Non-Abusers

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

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxycodone 15 mg

Drug

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

Other names: immediate-release oxycodone

Oxycodone 30 mg

Drug

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

Other names: immediate-release oxycodone

Placebo 0 mg

Drug

0 mg placebo dose administered once a day, orally.

Other names: 0 mg

Primary outcomes

  1. Breakpoint

    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

    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 outcomes

  1. Drug Liking

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Prescription Opioid Effects in Drug and Non-drug Abusers - 1

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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