NIDA-CSP-1020

Division
Investigator(s)
Title
A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal
Short Description
The value of this pivotal Phase 3 efficacy trial is to investigate if a nonopiate such as lofexidine, an alpha-2-adrenergic agonist, is an effective medication for the alleviation of opiate detoxification symptoms in opiate dependent individuals.
Release Date
Dec 21, 2017
Description

The primary outcome measure is the Modified Himmelsbach Opiate Withdrawal Scale (MHOWS), an objective assessment of the severity of opiate withdrawal symptoms, obtained on the second opiate detoxification day. It is hypothesized that the MHOWS scores will be significantly lower in the lofexidine as compared with the placebo group. Subjects will be medically discharged on the morning of the 11th day.

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Study Data
Study Links
Study Documents
Dictionary
Case Report Form(s)
Deidentification Notes