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A prospective study of off-label use of, abuse of, and dependence on nicotine inhaler

Abstract

Objective: To determine the incidence of off-label use of, abuse of, and dependence on prescription nicotine inhaler.

Design: Prospective telephone and internet interviews for six months.

Participants: 535 new inhaler users.

Main outcome: Structured interview about off-label use (that is, use of inhaler for non-cessation reasons or concurrent use of inhaler and cigarettes) and Diagnostic and statistical manual, fourth edition (DSM-IV) and International classification of diseases, 10th edition (ICD-10) criteria for abuse and dependence

Results: Although many used inhaler and cigarettes concurrently at some time (43–55%), few used inhaler for non-cessation reasons (4–9%) and few persisted in off label use (8–16%; 95% confidence interval (CI) 5% to 19%). No participant met ICD-10 criteria for harmful use/abuse (95% CI 0% to 3.3%). Eight subjects (1.4%) appeared to meet DSM-IV or ICD-10 criteria for dependence on inhaler, but none were found dependent in a clinical expert interview (95% CI 0% to 3.3%).

Conclusions: Although transient concurrent use of inhaler and cigarettes often occurs, use for non-cessation reasons, abuse and dependence are rare.

  • AE, adverse event
  • CATI, computer assisted telephone interview
  • COSTART, Coding symbols for Thesaurus of adverse reaction terms
  • DSM-IV, Diagnostic and statistical manual, fourth edition
  • FDA, Food and Drug Administration
  • FTND, Fagerstrom test for nicotine dependence
  • ICD-10, International classification of diseases, 10th edition
  • NRT, nicotine replacement therapy
  • OTC, over-the-counter
  • cessation
  • nicotine
  • nicotine dependence
  • nicotine inhaler
  • tobacco use disorder

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