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Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

Primary Purpose

Opioid Abuse

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acurox 5/30mg taken first

Oxycodone 5mg taken first

About this trial

This is an interventional treatment trial for Opioid Abuse focused on measuring Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Johns Hopkins Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Acurox 5/30mg taken first

Oxycodone 5mg taken first

Arm Description

oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose

oxycodone HCl 5mg tablets; 8 tablets per dose

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00699010

First Posted

June 13, 2008

Last Updated

September 6, 2018

Sponsor

Acura Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00699010

Brief Title

Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acura Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Abuse

Keywords

Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acurox 5/30mg taken first

Arm Type

Active Comparator

Arm Description

oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose

Arm Title

Oxycodone 5mg taken first

Arm Type

Active Comparator

Arm Description

oxycodone HCl 5mg tablets; 8 tablets per dose

Intervention Type

Drug

Intervention Name(s)

Acurox 5/30mg taken first

Intervention Description

followed by oxycodone 5mg with 48 hour washout

Intervention Type

Drug

Intervention Name(s)

Oxycodone 5mg taken first

Intervention Description

followed by Acurox 5/30mg with 48 hour washout

Primary Outcome Measure Information:

Title

Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)

Description

Time Frame

Effects assessed at 0.5 hours after dosing.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald R Jasinski, MD

Organizational Affiliation

Johns Hopkins Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

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