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Quality of Life Research
Gepubliceerd in:

01-08-2012 | Brief Communication

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

Auteurs: Thomas A. Eaton, Sandra D. Comer, Dennis A. Revicki, Jeremiah J. Trudeau, Richard G. van Inwegen, Joseph W. Stauffer, Nathaniel P. Katz

Gepubliceerd in: Quality of Life Research | Uitgave 6/2012

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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.
vorige artikel Factors associated with subjective quality of life in Korean patients with depressive disorders: the CRESCEND study
volgende artikel Quality of life of patients in renal replacement therapy in Brazil: comparison of treatment modalities
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Metagegevens
Titel
Determining the clinically important difference in visual analog scale scores in abuse liability studies evaluating novel opioid formulations
Auteurs
Thomas A. Eaton
Sandra D. Comer
Dennis A. Revicki
Jeremiah J. Trudeau
Richard G. van Inwegen
Joseph W. Stauffer
Nathaniel P. Katz
Publicatiedatum
01-08-2012
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 6/2012
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-011-0012-7

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