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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00158184 |
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 |
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Opioid-Related Disorders Substance-Related Disorders |
Drug: oxycodone |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Prescription Opioid Effects in Drug and Non-Drug Abusers - 1 |
Estimated Enrollment: | 96 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Experimental: Experimental
Placebo and active drug are administered during the study
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Drug: oxycodone
Placebo, 15 mg/70 kg oxycodone, and 30 mg/70 kg oxycodone are administered once per day
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Non-drug abusers:
Contact: Sandra Comer, PhD | 212-543-5981 |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: James Mckay, PhD 212-543-5981 sdc10@columbia.edu |
Principal Investigator: | Sandra Comer, PhD | New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute and Columbia University ( Sandra D. Comer, PhD ) |
Study ID Numbers: | NIDA-16759-1, R01-16759-1, DPMC |
Study First Received: | September 8, 2005 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00158184 History of Changes |
Health Authority: | United States: Federal Government |
Mental Disorders Oxycodone Substance-Related Disorders Central Nervous System Depressants Disorders of Environmental Origin |
Narcotics Peripheral Nervous System Agents Analgesics Opioid-Related Disorders Analgesics, Opioid |
Disease Oxycodone Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Depressants Narcotics Opioid-Related Disorders Pharmacologic Actions Pathologic Processes |
Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |