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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00734461
• Date of registration: 12/08/2008
• Primary sponsor: Pain Therapeutics
• Public title: Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
• Scientific title: A Single-Center, Randomized, Double-Blind, Active- and Placebo-Controlled Crossover Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse
• Date of first enrolment: August 2007
• Target sample size: 14
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00734461
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: George E Bigelow, PhD
• Affiliation: Johns Hopkins School of Medicine

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Opioid-Related Disorders

Intervention(s)

Drug: oxycodone and naltrexone

Primary Outcome(s)

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. [Time Frame: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose]

Secondary Outcome(s)

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. [Time Frame: At 30, 60, 90, 120, 150, 180 and 210 minutes post-dose]

Secondary ID(s)

PTI-801-XM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors