| June 13, 2008 |
| October 22, 2008 |
| March 2008 |
| August 2008 (final data collection date for primary outcome measure) |
- 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 ]
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| Same as current |
| Complete list of historical versions of study NCT00699010 on ClinicalTrials.gov Archive Site |
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| Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse |
| 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: (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. |
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| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
| Opioid Abuse |
- Drug: Niacin
- Drug: Oxycodone HCL plus Niacin
- Drug: Placebo
- Drug: Oxycodone HCl
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| Completed |
| 30 |
| August 2008 |
| August 2008 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years to 55 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00699010 |
| Donald R. Jasinski, MD, Johns Hopkins Medical Center |
| AP-ADF-111 |
| Acura Pharmaceuticals Inc. |
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| Principal Investigator: |
Donald R Jasinski, MD |
Johns Hopkins Medical Center |
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| Acura Pharmaceuticals Inc. |
| October 2008 |