A prospective study of off-label use of, abuse of, and dependence on nicotine inhaler
- 1University of Vermont, Department of Psychiatry, Burlington, Vermont, USA
- 2Harris Interactive, Rochester, New York, USA
- 3Pfizer Consumer Healthcare, Morris Plains, New Jersey, USA
- 4Lansdale, Pennsylvania, USA
- 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
- Received 25 March 2004
- Accepted 16 September 2004
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








