Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
This study has been completed.
Sponsor:
Acura Pharmaceuticals Inc.
Information provided by:
Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00699010
First received: June 13, 2008
Last updated: October 22, 2008
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is: (1) to assess the effect of oxycodone HCl on niacin-induced dysphoric effects when oxycodone HCl is administered in combination with niacin in subjects with a history of opioid abuse; (2) to assess the abuse liability of 4 times 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Abuse |
Drug: Niacin Drug: Oxycodone HCL plus Niacin Drug: Placebo Drug: Oxycodone HCl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Acura Pharmaceuticals Inc.:
Primary Outcome Measures:
- Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ] [ Designated as safety issue: Yes ]
- Evaluation of the DRQS, the ARCI, the Street Value Assessment Questionnaire (SVAQ), and the Treatment Enjoyment Assessment Questionnaire (TEAQ) [ Time Frame: Day 1, 3, 5, 7, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: Niacin
Niacin 240 mg every 48 hours
|
| Active Comparator: B |
Drug: Oxycodone HCL plus Niacin
Oxycodone HCL 40 mg plus Niacin 240 mg every 48 hours
|
| Placebo Comparator: C |
Drug: Placebo
Placebo every 48 hours
|
| Active Comparator: D |
Drug: Oxycodone HCL plus Niacin
Oxycodone HCl 40 mg plus Niacin 240 mg every 48 hours
|
| Active Comparator: E |
Drug: Oxycodone HCl
Oxycodone HCl 40 mg every 48 hours
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699010
Locations
| United States, Maryland | |
| Johns Hopkins Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
Sponsors and Collaborators
Acura Pharmaceuticals Inc.
Investigators
| Principal Investigator: | Donald R Jasinski, MD | Johns Hopkins Medical Center |
More Information
No publications provided
| Responsible Party: | Donald R. Jasinski, MD, Johns Hopkins Medical Center |
| ClinicalTrials.gov Identifier: | NCT00699010 History of Changes |
| Other Study ID Numbers: | AP-ADF-111 |
| Study First Received: | June 13, 2008 |
| Last Updated: | October 22, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Acura Pharmaceuticals Inc.:
|
Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders Niacin Nicotinic Acids Niacinamide Oxycodone Analgesics, Opioid Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Narcotics Central Nervous System Depressants Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013