Opioid AbusePhase 2NCT00699010
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
A Phase 2 study testing Acurox 5/30mg taken first and Oxycodone 5mg taken first in people with Opioid Abuse, run by Acura Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse
- What is being tested?
- Acurox 5/30mg taken first and Oxycodone 5mg taken first
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2008
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female between 18 and 55 years of age
- Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone
- Body weight is not more than 20% above or below ideal body weight
- Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the Investigator) or alcohol
- Subject is in generally good health
- Subject is reliable, willing, cooperative, able to communicate effectively, and has a minimum of a 6th grade reading level
- Subject has an acceptable score on the MMSE for cognitive impairment
- For women of child-bearing potential: woman is not pregnant and not nursing, and is practicing an acceptable method of birth control
Who cannot join
- Subject has a disease that may endanger the subject or the validity of the data
- Subject is currently physically dependent on opiates or alcohol
- Subject was exposed to any investigational drug within 30 days prior to the inpatient phase
- Subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation
- Subject has a positive urine drug screen for a non-opiate drug
- Subject has a predisposing condition that may place the subject at risk for receiving niacin or oxycodone, or confound the study analyses
- Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient phase
- Subject has an abnormal bleeding tendency
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Center
Baltimore, Maryland, 21224
About this study
Official title: A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Acurox (Oxycodone HCl and Niacin) Tablets in Subjects With a History of Opioid Abuse
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.
Read the detailed description
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose).
All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.
- Conditions
- Opioid Abuse
- Being tested
- Acurox 5/30mg taken first, Oxycodone 5mg taken first
- Keywords
- Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acurox 5/30mg taken firstDrug
followed by oxycodone 5mg with 48 hour washout
Oxycodone 5mg taken firstDrug
followed by Acurox 5/30mg with 48 hour washout
| Study group | Role | What they receive |
|---|---|---|
| Acurox 5/30mg taken first | Active comparator | oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose Receives: Drug: Acurox 5/30mg taken first |
| Oxycodone 5mg taken first | Active comparator | oxycodone HCl 5mg tablets; 8 tablets per dose Receives: Drug: Oxycodone 5mg taken first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).
Measured: Effects assessed at 0.5 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
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.
- Other trials for Opioid AbuseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acura Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald R Jasinski, MD, Principal investigator, Johns Hopkins Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699010
- Sponsor's protocol ID
- AP-ADF-111
- Status last verified
- Oct 2008
- First submitted
- 13 Jun 2008
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Acurox (Oxycodone HCl and Niacin) Tablets in Subjects With a History of Opioid Abuse
- ClinicalTrials.gov ID
- NCT00699010
- Acronym / sponsor ID
- AP-ADF-111
- Conditions
- Opioid Abuse
- Keywords
- Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acura Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 3 Oct 2018
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 assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.
Detailed description
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose).
All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acurox 5/30mg taken first | Active comparator | Drug: Acurox 5/30mg taken firstoxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose |
| Oxycodone 5mg taken first | Active comparator | Drug: Oxycodone 5mg taken firstoxycodone HCl 5mg tablets; 8 tablets per dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is male or female between 18 and 55 years of age
- Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone
- Body weight is not more than 20% above or below ideal body weight
- Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the Investigator) or alcohol
- Subject is in generally good health
Key exclusion criteria (8 listed)
- Subject has a disease that may endanger the subject or the validity of the data
- Subject is currently physically dependent on opiates or alcohol
- Subject was exposed to any investigational drug within 30 days prior to the inpatient phase
- Subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation
- Subject has a positive urine drug screen for a non-opiate drug
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 |
|---|---|---|
| Acurox 5/30mg taken firstfollowed by oxycodone 5mg with 48 hour washout | Drug | Acurox 5/30mg taken first |
| Oxycodone 5mg taken firstfollowed by Acurox 5/30mg with 48 hour washout | Drug | Oxycodone 5mg taken first |
Primary outcome
Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
Time frame: Effects assessed at 0.5 hours after dosing.
"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donald R Jasinski, MD principal investigator
Johns Hopkins Medical Center
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 Acurox 5/30mg taken first and Oxycodone 5mg taken first in people with Opioid Abuse, run by Acura Pharmaceuticals Inc. 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 8 inclusion and 8 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 3 Oct 2018. 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 3 Oct 2018). 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?
Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) (time frame: Effects assessed at 0.5 hours after dosing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2018.