Prescription Opioid Effects in Abusers Versus Non-Abusers

NCT ID: NCT00158184

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2009-06-30

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.

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Rx Opioid Abusers

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

Group Type: ACTIVE_COMPARATOR

oxycodone 15 mg

Intervention Type: DRUG

15 mg/70 kg oxycodone administered once per day, orally.

oxycodone 30 mg

Intervention Type: DRUG

30 mg/70 kg oxycodone administered once per day, orally.

Placebo 0 mg

Intervention Type: DRUG

0 mg placebo dose administered once a day, orally.

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.

Group Type: ACTIVE_COMPARATOR

oxycodone 15 mg

Intervention Type: DRUG

15 mg/70 kg oxycodone administered once per day, orally.

oxycodone 30 mg

Intervention Type: DRUG

30 mg/70 kg oxycodone administered once per day, orally.

Placebo 0 mg

Intervention Type: DRUG

0 mg placebo dose administered once a day, orally.

Interventions

oxycodone 15 mg

15 mg/70 kg oxycodone administered once per day, orally.

Intervention Type: DRUG

oxycodone 30 mg

30 mg/70 kg oxycodone administered once per day, orally.

Intervention Type: DRUG

Placebo 0 mg

0 mg placebo dose administered once a day, orally.

Intervention Type: DRUG

Other Intervention Names

immediate-release oxycodone; immediate-release oxycodone; 0 mg

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:

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Comer, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20079977 (View on PubMed)

Other Identifiers

R01DA016759-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#4691

Identifier Type: -

Identifier Source: org_study_id