Prescription Opioid Effects in Abusers Versus Non-Abusers
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Opioid-Related Disorders Substance-Related Disorders |
Drug: oxycodone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Prescription Opioid Effects in Drug and Non-drug Abusers - 1 |
- Progressive ratio breakpoint value [ Time Frame: Post-drug ] [ Designated as safety issue: No ]
| Enrollment: | 96 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental
Placebo and active drug are administered during the study
|
Drug: oxycodone
Placebo, 15 mg/70 kg oxycodone, and 30 mg/70 kg oxycodone are administered once per day
Other Name: immediate-release oxycodone
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
- 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
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Sandra Comer, PhD | New York State Psychiatric Institute |
More Information
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00158184 History of Changes |
| Other Study ID Numbers: | #4691, R01DA016759-01, R01 DA16759-01, DPMC |
| Study First Received: | September 8, 2005 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013