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Canadian Respiratory Journal
Volume 8, Issue 1, Pages 21-26
Original Article

Nicotine Replacement Combined with a Novel Compound (ProBAN) for Smoking Cessation: A Pilot Study

Richard Leigh,1 Norman M Viner,2 Gerard Cox,1 Jeffrey W Balon,3 Douglas MC Wilson,4 Denise O’Shaughnessy,1 Corinne Walker,1 Gerry Brosky,5 and Malcolm R Sears1

1Firestone Regional Chest and Allergy Unit, St Joseph’s Hospital – McMaster University, Hamilton, Ontario, Canada
2Synapse Pharmaceuticals International Inc, Ottawa, Ontario, Canada
3Holistic/Aim Clinic, Riverside Medical Centre, Ottawa, Ontario, Canada
4Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada
5Department of Family Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

Copyright © 2001 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


BACKGROUND: Smoking cessation rates with available pharmacological therapies remain suboptimal. Anecdotal observations with a combination of sublingual pralidoxime and ipratropium (ProBAN) suggested that these agents in combination with nicotine gum improved quit rates.

OBJECTIVE: To determine whether ProBAN together with nicotine replacement improves quit rates compared with nicotine replacement alone.

DESIGN: A 12-week, prospective, double-blind, randomized, placebo controlled pilot study. SETTING: University-affiliated outpatient clinic.

POPULATION STUDIED: Healthy adult smokers were recruited via advertisements. Of 107 subjects seen at the screening visit, 27 were excluded because of comorbid illness or concomitant medication use.

INTERVENTIONS: Of 80 eligible subjects, 40 were randomly assigned to receive treatment with ProBAN sub- lingual tablets and nicotine gum (treatment group), and 40 to receive placebo tablets and nicotine gum (control group) for 12 weeks. The primary outcome was complete continuous abstinence of smoking from one through 12 weeks after the quit date.

MAIN RESULTS: There were no adverse effects in the treatment group. At one week after the quit date, 35% of ProBAN-treated subjects had quit compared with 18% of control subjects (odds ratio [OR] 2.5, 95% CI 0.9 to 7.2). Corresponding quit rates at four weeks were 28% and 15% (OR 2.1, 95% CI 0.7 to 6.5), at eight weeks were 25% and 13% (OR 2.3, 95% CI 0.7 to 7.6), and at 12 weeks were 23% and 13% (OR 2.0, 95% CI 0.6 to 6.7), respectively.

CONCLUSIONS: This pilot study indicated that ProBAN combined with nicotine replacement doubled the continuous sustained quit rate compared with nicotine replacement alone, with no adverse effects. Although not statistically significant due to the size of the study, this result suggests that it may be an effective therapy for smoking cessation, and larger studies are warranted.