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Prescription Opioid Effects in Abusers Versus Non-Abusers

Primary Purpose

Opioid-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxycodone 15 mg
oxycodone 30 mg
Placebo 0 mg
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid-Related Disorders focused on measuring Opiate, Opioid, Abuse Liability, Abuse Potential

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rx Opioid Abusers

Rx Opioid Non-Abusers

Arm Description

Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.

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.

Outcomes

Primary Outcome Measures

Breakpoint
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

Drug Liking
Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."

Full Information

First Posted
September 8, 2005
Last Updated
June 8, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00158184
Brief Title
Prescription Opioid Effects in Abusers Versus Non-Abusers
Official Title
Prescription Opioid Effects in Drug and Non-drug Abusers - 1
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders
Keywords
Opiate, Opioid, Abuse Liability, Abuse Potential

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rx Opioid Abusers
Arm Type
Active Comparator
Arm Description
Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random.
Arm Title
Rx Opioid Non-Abusers
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxycodone 15 mg
Other Intervention Name(s)
immediate-release oxycodone
Intervention Description
15 mg/70 kg oxycodone administered once per day, orally.
Intervention Type
Drug
Intervention Name(s)
oxycodone 30 mg
Other Intervention Name(s)
immediate-release oxycodone
Intervention Description
30 mg/70 kg oxycodone administered once per day, orally.
Intervention Type
Drug
Intervention Name(s)
Placebo 0 mg
Other Intervention Name(s)
0 mg
Intervention Description
0 mg placebo dose administered once a day, orally.
Primary Outcome Measure Information:
Title
Breakpoint
Description
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.
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
Secondary Outcome Measure Information:
Title
Drug Liking
Description
Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."
Time Frame
Highest rating obtained following adminstration of each of the 3 test doses.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Comer, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20079977
Citation
Comer SD, Sullivan MA, Vosburg SK, Kowalczyk WJ, Houser J. Abuse liability of oxycodone as a function of pain and drug use history. Drug Alcohol Depend. 2010 Jun 1;109(1-3):130-8. doi: 10.1016/j.drugalcdep.2009.12.018. Epub 2010 Jan 15.
Results Reference
result

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Prescription Opioid Effects in Abusers Versus Non-Abusers

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