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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)975-981
Number of pages7
JournalQuality of Life Research
Volume21
Issue number6
DOIs
StatePublished - Aug 1 2012

Keywords

  • Abuse liability
  • Analgesics
  • Drug formulations
  • Drug high
  • Morphine
  • Opioid

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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