Prescription Opioid Effects in Abusers Versus Non-Abusers

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Oxycodone

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