The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials

Marc Mooney, Thom White, Dorothy Hatsukami

Research output: Contribution to journalArticlepeer-review

33 Scopus citations

Abstract

While clinical trials of medications often use a double-blind procedure, the integrity of the blind and its relationship to treatment outcome is seldom examined. In this review, 73 double-blind, placebo-controlled clinical trials of the nicotine replacement therapies (NRTs) in smoking cessation were identified. Seventeen articles were found that assessed blindness integrity, demonstrating major variations in the assessment, analysis, and reporting of blindness integrity. Although 12 studies found that subjects accurately judged treatment assignment at a rate significantly above chance, the available literature does not permit definitive conclusions about blindness integrity. Recommendations for the assessment, analysis, and reporting of blindness integrity are made.

Original languageEnglish (US)
Pages (from-to)673-684
Number of pages12
JournalAddictive Behaviors
Volume29
Issue number4
DOIs
StatePublished - Jun 2004

Bibliographical note

Funding Information:
Earlier versions of this analysis were presented at the annual Minnesota Undergraduate Psychology Conference in 2001 and at the Society for Research on Nicotine Tobacco's annual conference in 2002. This article was supported by National Institute of Drug Abuse Grant P50-DA13333.

Keywords

  • Compliance
  • Double blindness
  • Nicotine replacement
  • Placebo effect
  • Review

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