Prescription Opioid Effects in Abusers Versus Non-Abusers
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders; Substance-Related Disorders
Intervention: oxycodone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Sandra Comer, PhD, Principal Investigator, Affiliation: New York State Psychiatric Institute
Overall contact:
Sandra Comer, PhD, Phone: 212-543-5981
Summary
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.
Clinical Details
Official title: Prescription Opioid Effects in Drug and Non-Drug Abusers - 1
Study design: Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Progressive ratio breakpoint value
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Sandra Comer, PhD, Phone: 212-543-5981
New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
James Mckay, PhD, Phone: 212-543-5981, Email: sdc10@columbia.edu
Additional Information
Starting date: June 2004
Ending date: June 2009
Last updated: July 22, 2008
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