Prescription Opioid Effects in Abusers Versus Non-Abusers

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Treatments: Drug: Placebo 0 mg; Drug: oxycodone 30 mg; Drug: oxycodone 15 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00158184

#4691

R01DA016759-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts 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:

  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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Rx Opioid Abusers

Active Comparator group

Description:

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

Treatment:

Drug: oxycodone 30 mg

Drug: oxycodone 15 mg

Drug: Placebo 0 mg

Rx Opioid Non-Abusers

Active Comparator group

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.

Treatment:

Drug: oxycodone 30 mg

Drug: oxycodone 15 mg

Drug: Placebo 0 mg