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NCT00734461 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Opioid-Related Disorders, sponsored by Pain Therapeutics.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
1
Study location

NCT00734461 is a Phase 2 study of Opioid-Related Disorders that has completed, run by Pain Therapeutics. The registered enrollment target is 14 participants, below the 347-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00734461, a Phase 2 study of Opioid-Related Disorders, has completed, sponsored by Pain Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG oxycodone and naltrexone

Study Locations (1)

Maryland

  • Behavioral Pharmacology Research Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2007-08
Est. Completion 2009-03
Phase Phase 2

Sponsor

Pain Therapeutics

12 total trials

What the Registry Record Tells You About NCT00734461

The ClinicalTrials.gov registry entry for NCT00734461 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 347-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (96% lower). The listed sponsor is Pain Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid-Related Disorders appearing as the primary indexed condition, and to 1 intervention - of which oxycodone and naltrexone is the first listed.

NCT00734461 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00734461 about?

NCT00734461 is a clinical study titled "Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse". 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. Approx...

What is the current status of trial NCT00734461?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2007-08. Estimated completion is 2009-03.

What conditions does trial NCT00734461 study?

This clinical trial studies the following conditions: Opioid-Related Disorders.

What interventions are being tested in trial NCT00734461?

The interventions under investigation include: oxycodone and naltrexone (DRUG).

Who is sponsoring clinical trial NCT00734461?

This trial is sponsored by Pain Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00734461 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.