Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, randomized, 7-way crossover, double-blind, active and placebo-controlled study to evaluate the subjective effects of oxycodone combined with ultra-low dose naltrexone in comparison to oxycodone alone in non-physically dependent subjects with a history of opioid abuse. Approximately 14 subjects will be randomized to one of fourteen sequences selected from a balanced 7x7 Latin square design and its mirror image.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pain Therapeutics
• Treatments: Naltrexone; Oxycodone

Criteria

Inclusion Criteria:

• Males and females who are at least 18 and no more than 65 years of age.

• The subject is in good health as determined by medical history and physical examination.

• The subject is willing and able to speak, read, and understand English and provide written informed consent.

• The subject's urine drug screen and ethanol breath test are negative at check-in to the clinic.

• The subject has a history of polydrug abuse and: Has taken illicit opioids within the last 30 days; and/or Misused/abused prescription opioids within the last 30 days.

• The subject is willing and able to comply with all testing and requirements defined in the protocol.

• The subject must agree to refrain from caffeine and xanthine-containing products throughout the study, and to refrain from nicotine from 1 hour prior to each dosing until 4 hours after each dosing.

• The subject is willing and able to remain at the study site unit for the duration of the study.

• The subject has a positive response to oxycodone in the blinded qualifying period as defined by a VAS Liking score for oxycodone that is at least 20 points greater than that for placebo.

• Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or intrauterine device [IUD]). A negative pregnancy test result must be obtained for all females at screening and at check-in to the clinic.

Exclusion Criteria:

• The subject has a positive urine drug screen or ethanol breath test at check-in to the clinic.

• The subject has been taking prescription opioids daily for chronic pain or has been taking illicit or prescription opioids daily for recreational purposes for more than 20 days in the last month.

• The subject is enrolled in treatment for drug abuse or is actively seeking treatment for drug abuse.

• The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.

• The subject has had a clinically significant illness within 30 days preceding entry into this study.

• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.

• The subject has a history of an allergic reaction to oxycodone or structurally similar compounds (morphine, hydromorphone, hydrocodone, levorphanol, pentazocine, codeine, etc.), naltrexone or other narcotic agonists.

• The subject has used any prescription medication (besides hormonal contraceptives) or recreational drugs within 7 days or over-the-counter (OTC) medication within 48 hours of check-in to the clinic or intends to use any prescription, recreational drugs or OTC medication during the study that may interfere with the evaluation of study medication.

• The subject has used alcohol, grapefruit, or grapefruit juice 24 hours before check-in to the clinic or intends to use any of these products during the study.

• The subject is pregnant or breastfeeding.

• The subject has received an investigational drug within 30 days prior to initiation of this study.

• The subject exhibits signs/symptoms of opioid withdrawal during the 24-hour observation period after check-in.

• The subject has a history of hospitalization due to a psychiatric disorder within the previous year or a current major psychiatric disorder. (Substance abuse disorders are not exclusionary).

• The subject experiences any of the following within 4 hours after administration of oxycodone 30 mg during the blinded qualifying dosing period: adverse events requiring narcotic antagonist administration, emesis, or opioid toxicity (see Section 10.0).

• The subject is unwilling to reside in the study unit for the inpatient portion of the study or to cooperate fully with the investigator or site personnel.