Skip to main content
main-content

Tip

Swipe om te navigeren naar een ander artikel

01-08-2012 | Brief Communication | Uitgave 6/2012

Quality of Life Research 6/2012

Determining the clinically important difference in visual analog scale scores in abuse liability studies evaluating novel opioid formulations

Tijdschrift:
Quality of Life Research > Uitgave 6/2012
Auteurs:
Thomas A. Eaton, Sandra D. Comer, Dennis A. Revicki, Jeremiah J. Trudeau, Richard G. van Inwegen, Joseph W. Stauffer, Nathaniel P. Katz

Abstract

Purpose

This study determined how the magnitude of change in positive subjective responses predicts clinical outcome in a treatment setting. Specifically, we attempted to define what constitutes a clinically important difference (CID) in subjective responses.

Methods

A 100-mm visual analog scale (VAS) measured subjective ratings of drug “high,” calculated via an anchor-based method with published data from participants receiving sustained-release naltrexone (NTX) and heroin in a laboratory setting. The data were then compared to clinical outcomes in a treatment trial with sustained-release naltrexone. A distribution-based method subsequently analyzed data from participants who received ALO-01 (extended-release morphine with sequestered NTX) to predict its abuse liability.

Results

Differences in ratings of drug high of approximately 10 mm on a 100-mm line were clinically significant. By extrapolation, CIDs were also found between crushed or intact ALO-01 and immediate-release morphine sulfate (IRMS). No CIDs were found between intact and crushed ALO-01.

Conclusions

From laboratory and treatment trial data involving naltrexone, calculation of CIDs in subjective ratings of high is possible. Consequently, crushing/swallowing or injecting ALO-01 produces clinically significantly less drug high than oral or intravenous morphine alone, suggesting that ALO-01 has lower abuse liability by those routes than morphine formulations.

Log in om toegang te krijgen

Met onderstaand(e) abonnement(en) heeft u direct toegang:

BSL Podotherapeut Totaal

Binnen de bundel kunt u gebruik maken van boeken, tijdschriften, e-learnings, web-tv's en uitlegvideo's. BSL Podotherapeut Totaal is overal toegankelijk; via uw PC, tablet of smartphone.

Literatuur
Over dit artikel

Andere artikelen Uitgave 6/2012

Quality of Life Research 6/2012Naar de uitgave