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A prospective study of off-label use of, abuse of, and dependence on nicotine inhaler
  1. J R Hughes1,
  2. E H Adams2,
  3. M A Franzon3,
  4. M K Maguire4,
  5. J Guary2
  1. 1University of Vermont, Department of Psychiatry, Burlington, Vermont, USA
  2. 2Harris Interactive, Rochester, New York, USA
  3. 3Pfizer Consumer Healthcare, Morris Plains, New Jersey, USA
  4. 4Lansdale, Pennsylvania, USA
  1. Correspondence to:
 John R Hughes MD
 Department of Psychiatry, Psychology & Family Practice, University of Vermont, 38 Fletcher Place, Burlington, VT 05401-1419, USA; john.hughesuvm.edu

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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