Opioid-Related Disorders, Substance-Related Disorders
Conditions
Keywords
Opiate, Opioid, Abuse Liability, Abuse Potential
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.
Interventions
DRUGoxycodone 15 mg
15 mg/70 kg oxycodone administered once per day, orally.
DRUGoxycodone 30 mg
30 mg/70 kg oxycodone administered once per day, orally.
DRUGPlacebo 0 mg
0 mg placebo dose administered once a day, orally.
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breakpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| Drug Liking | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rx Opioid Abusers Prescription Opioids users with abusive patterns of use. | 16 |
| Rx Opioid Medical Users Prescription Opioids users without abusive patterns of use. | 11 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | failed for follow unit/study rules | 2 | 0 |
| Overall Study | personal issues | 3 | 1 |
Baseline characteristics
| Characteristic | Rx Opioid Abusers | Rx Opioid Medical Users | Total |
|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 8 | 28 years STANDARD_DEVIATION 6 | 30 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 16 participants | 11 participants | 27 participants |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 0 / 11 |
| serious Total, serious adverse events | 0 / 16 | 0 / 11 |
Outcome results
Primary
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.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rx Opioid Abusers | Breakpoint | Placebo: 0 mg | 25 Mouse Clicks | Standard Error 20 |
| Rx Opioid Abusers | Breakpoint | Oxycodone: 15mg | 1400 Mouse Clicks | Standard Error 400 |
| Rx Opioid Abusers | Breakpoint | Oxycodone: 30mg | 1100 Mouse Clicks | Standard Error 350 |
| Rx Opioid Non-Abusers | Breakpoint | Oxycodone: 30mg | 900 Mouse Clicks | Standard Error 160 |
| Rx Opioid Non-Abusers | Breakpoint | Placebo: 0 mg | 400 Mouse Clicks | Standard Error 200 |
| Rx Opioid Non-Abusers | Breakpoint | Oxycodone: 15mg | 850 Mouse Clicks | Standard Error 100 |
Secondary
Drug Liking
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rx Opioid Abusers | Drug Liking | Placebo: 0 mg | 23 units on a scale | Standard Error 5 |
| Rx Opioid Abusers | Drug Liking | Oxycodone: 30 mg | 59 units on a scale | Standard Error 8 |
| Rx Opioid Abusers | Drug Liking | Oxycodone: 15 mg | 60 units on a scale | Standard Error 7 |
| Rx Opioid Non-Abusers | Drug Liking | Oxycodone: 15 mg | 53 units on a scale | Standard Error 8 |
| Rx Opioid Non-Abusers | Drug Liking | Oxycodone: 30 mg | 40 units on a scale | Standard Error 9 |
| Rx Opioid Non-Abusers | Drug Liking | Placebo: 0 mg | 21 units on a scale | Standard Error 7 |