Clinical trial NCT00158184: Prescription Opioid Effects in Abusers Versus Non-Abusers
Official title: Prescription Opioid Effects in Drug and Non-drug Abusers - 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: Opiate
Opioid
Abuse Liability
Abuse Potential
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-12
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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 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.

Eligibility 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

Primary outcomes:
measure: Breakpoint
timeFrame: 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
Secondary outcomes:
measure: Drug Liking
timeFrame: Highest rating obtained following adminstration of each of the 3 test doses.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Sandra Comer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.