Status:
COMPLETED
Prescription Opioid Effects in Abusers Versus Non-Abusers
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Substance-Related Disorders
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00158184
Start Date
June 1 2004
End Date
June 1 2009
Last Update
July 7 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032