A randomized trial of the effects of two novel nicotine replacement therapies on tobacco withdrawal symptoms and user satisfaction.
OBJECTIVE
To determine effects on craving, user satisfaction, and consumption patterns of two new nicotine replacement therapies (NRT) used for eight hours after overnight tobacco abstinence.


METHODS
In a within-subject, cross-over trial participants were randomly assigned Zonnic nicotine mouth spray (1 mg/spray), Zonnic nicotine lozenge (2.5 mg), Nicorette gum (4 mg) and placebo lozenge on each of four study days.


METHODS
University research unit.


METHODS
Forty-seven dependent adult smokers.


METHODS
Participants rated their urges to smoke, irritability, concentration and restlessness before and during the first hour of product use on a 100-point scale. A subsample of 11 participants provided blood samples for nicotine analysis.


RESULTS
All active products reduced craving significantly more than placebo (mean reductions of 28.6, 25.8, 24.7 and 8.9 points for mouth spray, gum, lozenge and placebo). Mouth spray relieved craving faster than placebo and gum with significant reductions within five minutes of use (mean differences of -14.5 (95% CI: -23.0 to -6.0) and -10.6 (95% CI: -19.1 to -2.1) with placebo and gum respectively. Mouth spray produced a faster time to maximum plasma nicotine concentration (14.5 minutes, 95% CI: 8.0 to 21.0) compared to the lozenge (30.3 minutes, 95% CI: 21.1 to 39.5) and gum (45.8 minutes, 95% CI: 36.2 to 55.4). Maximum concentrations of blood nicotine were higher with mouth spray (10.0 ng/ml) and lozenge (10.8 ng/ml) compared to gum (7.8 ng/ml). Both lozenge and mouth spray were well tolerated.


CONCLUSIONS
The mouth spray and lozenge are at least as effective as 4 mg nicotine gum in relieving craving suggesting that they are likely to be effective in aiding smoking cessation. The mouth spray may be particularly useful for acute craving relief.
McRobbie
Hayden
H
Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, UK. h.j.mcrobbie@qmul.ac.uk
Thornley
Simon
S
Bullen
Chris
C
Lin
Ruey-Bin
RB
Senior
Hugh
H
Laugesen
Murray
M
Whittaker
Robyn
R
Hajek
Peter
P
D000278:Administration, Buccal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000493:pharmacokinetics; D017060:Patient Satisfaction; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D018722:Nicotinic Agonists; D009538:Nicotine