Opioid AbusePhase 2NCT01030406
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
A Phase 2 study testing 40/0mg taken first, 80/0mg taken first and 40/240mg taken first in people with Opioid Abuse, run by Acura Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users. 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?
- 40/0mg taken first, 80/0mg taken first and 40/240mg taken first
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2010
- 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 old.
- Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.
- Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will provide written informed consent.
- Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).
Who cannot join
- History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
- History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
- Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
Read the detailed description
In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.
- Conditions
- Opioid Abuse
- Being tested
- 40/0mg taken first, 80/0mg taken first, 40/240mg taken first, 80/480mg taken first, 0/0mg 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.
40/0mg taken firstDrug
8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
80/0mg taken firstDrug
8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
40/240mg taken firstDrug
8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
80/480mg taken firstDrug
8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
0/0mg taken firstDrug
Placebo All arms taken with a 48 hour washout between doses
| Study group | Role | What they receive |
|---|---|---|
| 40/0mg taken first | Active comparator | 8x oxycodone/niacin 5/0mg tablets Receives: Drug: 40/0mg taken first |
| 80/0mg taken first | Active comparator | 8x oxycodone/niacin 10/0mg tablets Receives: Drug: 80/0mg taken first |
| 40/240mg taken first | Experimental | 8x oxycodone/niacin 5/30mg tablets Receives: Drug: 40/240mg taken first |
| 80/480mg taken first | Experimental | 8x oxycodone/niacin 10/60mg tablets Receives: Drug: 80/480mg taken first |
| 0/0mg taken first | Placebo comparator | Placebo Receives: Drug: 0/0mg taken first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking at .5 Hours
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
Measured: Measure collected at 0.5 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionFeb 2010
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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acura Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Lynne Webster, MD, Principal investigator, Lifetree Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030406
- Sponsor's protocol ID
- AP-ADF-114
- Status last verified
- Mar 2010
- First submitted
- 10 Dec 2009
- Last updated
- 1 Nov 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 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT01030406
- Acronym / sponsor ID
- AP-ADF-114
- Conditions
- Opioid Abuse
- Keywords
- Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Acura Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 1 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
Detailed description
In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 40/0mg taken first | Active comparator | Drug: 40/0mg taken first8x oxycodone/niacin 5/0mg tablets |
| 80/0mg taken first | Active comparator | Drug: 80/0mg taken first8x oxycodone/niacin 10/0mg tablets |
| 40/240mg taken first | Experimental | Drug: 40/240mg taken first8x oxycodone/niacin 5/30mg tablets |
| 80/480mg taken first | Experimental | Drug: 80/480mg taken first8x oxycodone/niacin 10/60mg tablets |
| 0/0mg taken first | Placebo comparator | Drug: 0/0mg taken firstPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is male or female between 18 and 55 years old.
- Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.
- Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will provide written informed consent.
- Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).
Key exclusion criteria (3 listed)
- History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
- History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
- Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.
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 |
|---|---|---|
| 40/0mg taken first8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses | Drug | 40/0mg taken first |
| 80/0mg taken first8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses | Drug | 80/0mg taken first |
| 40/240mg taken first8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses | Drug | 40/240mg taken first |
| 80/480mg taken first8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses | Drug | 80/480mg taken first |
| 0/0mg taken firstPlacebo All arms taken with a 48 hour washout between doses | Drug | 0/0mg taken first |
Primary outcome
Drug Liking at .5 Hours
Time frame: Measure collected at 0.5 hours post-dose
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
Lynne Webster, MD principal investigator
Lifetree Clinical Research
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 40/0mg taken first, 80/0mg taken first and 40/240mg 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 4 inclusion and 3 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 1 Nov 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. Some participants in this study may receive a placebo. 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 1 Nov 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 Liking at .5 Hours (time frame: Measure collected at 0.5 hours post-dose). 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 1 Nov 2018.