RESEARCH PAPER

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

J R Hughes¹, E H Adams², M A Franzon³, M K Maguire⁴, J Guary²

¹ University of Vermont, Department of Psychiatry, Burlington, Vermont, USA
² Harris Interactive, Rochester, New York, USA
³ Pfizer Consumer Healthcare, Morris Plains, New Jersey, USA
⁴ Lansdale, Pennsylvania, USA

Correspondence to:
Correspondence to:
John R Hughes MD
Department of Psychiatry, Psychology & Family Practice, University of Vermont, 38 Fletcher Place, Burlington, VT 05401-1419, USA; john.hughes{at}uvm.edu

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.

Abbreviations: 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

Keywords: cessation; nicotine; nicotine dependence; nicotine inhaler; tobacco use disorder

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