Determining the clinically important difference in visual analog scale scores in abuse liability studies evaluating novel opioid formulations.
Qual Life Res
; 21(6): 975-81, 2012 Aug.
Article
en En
| MEDLINE
| ID: mdl-21964915
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.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Heroína
/
Analgésicos Opioides
/
Naltrexona
/
Trastornos Relacionados con Opioides
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Qual Life Res
Asunto de la revista:
REABILITACAO
/
TERAPEUTICA
Año:
2012
Tipo del documento:
Article