Opioid-Related DisordersPhase 2NCT00158184
Prescription Opioid Effects in Abusers Versus Non-Abusers
A Phase 2 study testing oxycodone 15 mg and oxycodone 30 mg in people with Opioid-Related Disorders and Substance-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders
- What is being tested?
- oxycodone 15 mg and oxycodone 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Prescription Opioid Effects in Drug and Non-drug Abusers - 1
The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.
Read the 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.
- Being tested
- oxycodone 15 mg, oxycodone 30 mg, Placebo 0 mg
- Keywords
- Opiate, Opioid, Abuse Liability, Abuse Potential
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodone 15 mgDrug
Also called immediate-release oxycodone
15 mg/70 kg oxycodone administered once per day, orally.
oxycodone 30 mgDrug
Also called immediate-release oxycodone
30 mg/70 kg oxycodone administered once per day, orally.
Placebo 0 mgDrug
Also called 0 mg
0 mg placebo dose administered once a day, orally.
| Study group | Role | What they receive |
|---|---|---|
| Rx Opioid Abusers | Active comparator | Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random. Receives: Drug: oxycodone 15 mg; Drug: oxycodone 30 mg; Drug: Placebo 0 mg |
| Rx Opioid Non-Abusers | Active comparator | 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. Receives: Drug: oxycodone 15 mg; Drug: oxycodone 30 mg; Drug: Placebo 0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Drug Liking
Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."
Measured: Highest rating obtained following adminstration of each of the 3 test doses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sandra Comer, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158184
- Sponsor's protocol ID
- #4691
- Other IDs
- R01DA016759-01
- Status last verified
- Jun 2017
- First submitted
- 8 Sep 2005
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20079977
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Opioid Effects in Drug and Non-drug Abusers - 1
- ClinicalTrials.gov ID
- NCT00158184
- Acronym / sponsor ID
- #4691
- Keywords
- Opiate, Opioid, Abuse Liability, Abuse Potential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 7 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rx Opioid Abusers | Active comparator | Drug: oxycodone 15 mg, Drug: oxycodone 30 mg, Drug: Placebo 0 mgRecreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random. |
| Rx Opioid Non-Abusers | Active comparator | Drug: oxycodone 15 mg, Drug: oxycodone 30 mg, Drug: Placebo 0 mgParticipants 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- On parole or probation
- Recently convicted of a crime of violence
- History of significant violent behavior
- Current Axis I psychopathology
- Significant Axis II disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxycodone 15 mgAlso: immediate-release oxycodone15 mg/70 kg oxycodone administered once per day, orally. | Drug | Rx Opioid Abusers, Rx Opioid Non-Abusers |
| oxycodone 30 mgAlso: immediate-release oxycodone30 mg/70 kg oxycodone administered once per day, orally. | Drug | Rx Opioid Abusers, Rx Opioid Non-Abusers |
| Placebo 0 mgAlso: 0 mg0 mg placebo dose administered once a day, orally. | Drug | Rx Opioid Abusers, Rx Opioid Non-Abusers |
Primary outcome
Breakpoint
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
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.
1 secondary outcome
Drug Liking
Time frame: Highest rating obtained following adminstration of each of the 3 test doses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20079977Comer 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.
- Individual participant dataSharing planned: No
Related trials for Opioid-Related Disorders
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingPhase 2
A Study of Brenipatide in Participants With Opioid Use Disorder
Opioid Use Disorder
RecruitingPhase 1
Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
Opioid Use, Substance Use Disorders
Recruiting
Using Facebook to Support Opioid Recovery Among American Indian Women
Opioid Use Disorder
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Comer, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxycodone 15 mg and oxycodone 30 mg in people with Opioid-Related Disorders and Substance-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breakpoint (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00158184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.