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NIDA-CSP-1020

Division

DTMC

HEAL Study

Investigator(s)

Ann Montgomery, R.N.

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.

Keywords

lofexidine

opiate

phase 3

Assessments

Addiction Research Center Inventory

Clinical Global Impression Scales

Modified Himmelsbach Opiate Withdrawal Scale

Objective Opiate Withdrawal Scale

Short Opiate Withdrawal Scale

Subjective Opiate Withdrawal Scale

Visual Analog Scales