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

NCT00734461 | Completed Phase 2

• 1 other identifier: PTI-801-XM
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-Related Disorders

Keywords

Non-physically dependent subjects; history of opioid abuse

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the subjective effects of PTI-801 formulated with either 0.001 mg naltrexone or 0.0001 mg naltrexone compared to oxycodone alone in individuals with a history of opioid abuse.

  At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose

Secondary Outcomes (1)

• Secondary objectives include determining the safety and physiological effects of single doses of PTI-801 compared to oxycodone following oral administration in individuals with a history of opioid abuse.

  At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Placebo, single dose

Drug: oxycodone and naltrexone

Oxycodone 20 mg

ACTIVE COMPARATOR

Oxycodone 20 mg single dose tablet

Drug: oxycodone and naltrexone

Oxycodone 40 mg

ACTIVE COMPARATOR

Oxycodone 40 mg single dose tablet

Drug: oxycodone and naltrexone

PTI-801 20/.001 mg

EXPERIMENTAL

Oxycodone 20 mg / Naltrexone 0.001 mg

Drug: oxycodone and naltrexone

PTI-801 40/.001 mg

EXPERIMENTAL

Oxycodone 40 mg / Naltrexone 0.001 mg

Drug: oxycodone and naltrexone

PTI-801 20/.0001 mg

EXPERIMENTAL

Oxycodone 40 mg / Naltrexone 0.0001 mg

Drug: oxycodone and naltrexone

PTI-801 40/.0001 mg

EXPERIMENTAL

Oxycodone 40 mg / Naltrexone 0.0001 mg

Drug: oxycodone and naltrexone

Interventions

oxycodone and naltrexone DRUG

tablets containing 20 mg or 40 mg oxycodone / tablets containing 20 mg or 40 mg oxycodone combined w/0.001 mg or 0.0001 mg naltrexone

Oxycodone 20 mg; Oxycodone 40 mg; PTI-801 20/.0001 mg; PTI-801 20/.001 mg; PTI-801 40/.0001 mg; PTI-801 40/.001 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Pain Therapeutics: lead

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224-6823, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Oxycodone; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Study Officials

• George E Bigelow, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 2, 2016

Record last verified: 2016-03

Locations

US (1)