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.

Condition	Phase
Opioid-Related Disorders Substance-Related Disorders alcohol & drug use	Phase II

Further Study Details: 

Expected Total Enrollment:  96

Two studies will be performed during the grant period: One study will examine the abuse liability of oxycodone and the other will examine the abuse liability of codeine in the two groups of participants (prescription opioid abusers and non-abusers).

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Physically healthy men and women
• Women reporting regular menstrual cycles lasting between 24 to 35 days
• Able to perform study procedures
• Normal body weight
• Use of opioids for medical (cough, pain, 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:

• Participants on parole or probation

Participants recently convicted of a crime of violence

• History of significant violent behavior
• Current Axis I psychopathology, or significant Axis II disorder
• Pregnancy
• Women who have irregular menstrual cycles, or who are dysmennorheic, amenorrheic, or menopausal
• Nursing mothers, women who have been pregnant, or had a miscarriage or abortion within the past 6 months
• Women who meet DSM-IV criteria for Premenstrual Dysphoric Disorder or report suffering from moderate to severe premenstrual symptoms, or are seeking treatment for premenstrual problems
• Participants who are taking prescription or over-the-counter psychotropic medication
• Participants who have a history of chronic pain, or routinely use over-the-counter analgesics (more than 4 days per month)
• Blood pressure greater than 150/90
• Participants who report sensitivity, allergy, or contraindication to opioids

Non-drug abusers only:

• Current or lifetime history of substance abuse or dependence (those requiring detoxification) according to DSM-IV criteria; participants who consume more than 500 mg caffeine daily will also be excluded
• Participants seeking treatment for their substance use

Please refer to this study by ClinicalTrials.gov identifier  NCT00158184

Sandra Comer, Ph.D.      (212)543-5981 

New York
      New York State Psychiatric Institute, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

Sandra Comer, Ph.D.,  Principal Investigator,  New York State Psychiatric Institute   

Study ID Numbers:  NIDA-16759-1; R01-16759-1
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158184
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13