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Prescription Opioid Effects in Abusers Versus Non-Abusers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00158184
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: oxycodone 15 mg Drug: oxycodone 30 mg Drug: Placebo 0 mg Phase 2

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 study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Prescription Opioid Effects in Drug and Non-drug Abusers - 1
Study Start Date : June 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Rx Opioid Abusers
Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
 Drug: oxycodone 15 mg
15 mg/70 kg oxycodone administered once per day, orally.
Other Name: immediate-release oxycodone

Drug: oxycodone 30 mg
30 mg/70 kg oxycodone administered once per day, orally.
Other Name: immediate-release oxycodone

Drug: Placebo 0 mg
0 mg placebo dose administered once a day, orally.
Other Name: 0 mg
Active Comparator: Rx Opioid Non-Abusers
Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
 Drug: oxycodone 15 mg
15 mg/70 kg oxycodone administered once per day, orally.
Other Name: immediate-release oxycodone

Drug: oxycodone 30 mg
30 mg/70 kg oxycodone administered once per day, orally.
Other Name: immediate-release oxycodone

Drug: Placebo 0 mg
0 mg placebo dose administered once a day, orally.
Other Name: 0 mg


Outcome Measures
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Primary Outcome Measures :
  1. Breakpoint [ Time Frame: Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session ]
    Maximum number of finger presses on a computer mouse completed. The "Breakpoint" is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability.


Secondary Outcome Measures :
  1. Drug Liking [ Time Frame: Highest rating obtained following adminstration of each of the 3 test doses. ]
    Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158184


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Sandra Comer, PhD New York State Psychiatric Institute
More Information
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Publications of Results:

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00158184    
Other Study ID Numbers: #4691
R01DA016759-01 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by New York State Psychiatric Institute:
Opiate
Opioid
Abuse Liability
Abuse Potential
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders
Oxycodone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents