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Prescription Opioid Effects in Abusers Versus Non-Abusers

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00158184
First received: September 8, 2005
Last updated: June 8, 2017
Last verified: June 2017
September 8, 2005
June 8, 2017
June 2004
June 2009   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00158184 on ClinicalTrials.gov Archive Site
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."
Not Provided
Not Provided
Not Provided
 
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 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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Basic Science
  • Opioid-Related Disorders
  • Substance-Related Disorders
  • Drug: oxycodone 15 mg
    15 mg/70 kg oxycodone administered once per day, orally.
    Other Name: immediate-release oxycodone
  • Drug: oxycodone 30 mg
    30 mg/70 kg oxycodone administered once per day, orally.
    Other Name: immediate-release oxycodone
  • Drug: Placebo 0 mg
    0 mg placebo dose administered once a day, orally.
    Other Name: 0 mg
  • Active Comparator: Rx Opioid Abusers
    Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
    Interventions:
    • Drug: oxycodone 15 mg
    • Drug: oxycodone 30 mg
    • Drug: Placebo 0 mg
  • Active Comparator: Rx Opioid Non-Abusers
    Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
    Interventions:
    • Drug: oxycodone 15 mg
    • Drug: oxycodone 30 mg
    • Drug: Placebo 0 mg
Comer SD, Sullivan MA, Vosburg SK, Kowalczyk WJ, Houser J. Abuse liability of oxycodone as a function of pain and drug use history. Drug Alcohol Depend. 2010 Jun 1;109(1-3):130-8. doi: 10.1016/j.drugalcdep.2009.12.018. Epub 2010 Jan 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
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
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00158184
#4691
R01DA016759-01 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: 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
June 2017

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