Nicotine replacement combined with a novel compound (ProBAN) for smoking cessation: a pilot study.
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.


METHODS
A 12-week, prospective, double-blind, randomized, placebo controlled pilot study.


METHODS
University-affiliated outpatient clinic.


METHODS
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.


METHODS
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.


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.
Leigh
R
R
Firestone Regional Chest and Allergy Unit, St Joseph's Hospital, Hamilton, Canada.
Viner
N M
NM
Cox
G
G
Balon
J W
JW
Wilson
D M
DM
O'Shaughnessy
D
D
Walker
C
C
Brosky
G
G
Sears
M R
MR
D000286:Administration, Sublingual; D000328:Adult; D002638:Chewing Gum; D002801:Cholinesterase Reactivators / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D010865:Pilot Projects; D011220:Pralidoxime Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D016540:Smoking Cessation / Q000379:methods*
D002638:Chewing Gum; D002801:Cholinesterase Reactivators; D004338:Drug Combinations; D011220:Pralidoxime Compounds; D009538:Nicotine; D009241:Ipratropium; C028797:pralidoxime