Phase 2
N=27
Prescription Opioid Effects in Abusers Versus Non-Abusers
Opioid-Related Disorders · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00158184 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Breakpoint — 25; 400; 1400; 850 Mouse Clicks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oxycodone 15 mg (Drug); oxycodone 30 mg (Drug); Placebo 0 mg (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breakpoint |
25; 400; 1400; 850; 1100; 900 | — |
| SECONDARY Drug Liking |
23; 21; 60; 53; 59; 40 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00158184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.