Nicotine quick-fix mouth spray helps some quitters
Andrey Nailor, M.D.·Published 28 February 2012·8 min read
Key points
A mouth spray that delivers a dose of nicotine faster than patches and gums may help some smokers quit long-term, suggests a new study from Scandinavian and German researchers.
A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy such as a faster uptake of nicotine and faster relief of craving.
In a controlled trial lasting a year, they found that compared with a non-medicated "placebo" spray, the nicotine mouth spray helped more than twice as many smokers quit.
Nicotine replacement therapy (NRT) is one option for helping smokers kick the habit.
A mouth spray that delivers a dose of nicotine faster than patches and gums may help some smokers quit long-term, suggests a new study from Scandinavian and German researchers.
In a controlled trial lasting a year, they found that compared with a non-medicated "placebo" spray, the nicotine mouth spray helped more than twice as many smokers quit. One reason, the team writes in the European Respiratory Journal, could be rapid delivery of nicotine to the bloodstream to relieve cravings when they strike.
Nicotine replacement therapy (NRT) is one option for helping smokers kick the habit. And NRT in the form of patches, gums, lozenges and nasal sprays has long been on the market.
NRT mouth sprays are newer and not available everywhere, including the U.S.
The mint-flavored sprays are designed to give people a more quickly-absorbed dose of nicotine compared with gums and other forms of NRT, and to be less irritating than nasal sprays.
The mouth sprays can also be used at will to alleviate withdrawal symptoms, versus skin patches, for example, which deliver a steady dose of nicotine to the blood over the course of the day.
But little has been known about how well the mouth sprays work in helping smokers quit.
Nicotine mouth spray launched Nicorette QuickMist: first oromucosal nicotine spray
Two new products have been added to the Nicorette smoking cessation range.
Nicorette QuickMist is the first oromucosal spray formulation of nicotine. Each dose of the mint-flavoured spray delivers 1mg of nicotine. Nicorette 2mg Lozenges, also mint-flavoured, are the other addition to the range.
Both products should be taken when cravings occur. Like other nicotine replacement products, they are suitable for use in pregnant and lactating women making a quit attempt.
In the new study, almost 14 percent of smokers who used the spray for three months were abstinent at the one-year mark, versus about six percent of those given the placebo spray.
That's not a huge number. But the benefit relative to placebo was larger than what's been seen with other NRT products, said lead researcher Dr. Philip Tonnesen, of Gentofte Hospital in Copenhagen, Denmark.
Nicotine Mouth Spray Is Preferred Replacement Therapy For Smoking Cessation This pilot study recently published in the journal "Respiration" shows that nicotine mouth spray is a preferred replacement therapy despite a higher rate of local adverse effects compared to oral inhalers and gum.
Various formulations of nicotine replacement therapy are commercially available. It was the aim of this study to test preference, safety and efficacy of a new nicotine mouth spray (1 mg/actuation; NicoNovum). To this effect, 100 healthy smokers wanting to quit (mean age 43.1 ± 11.2 years) were included. They were given the mouth spray, as well as 2-mg nicotine gums and nicotine oral inhalers to try out for 1 week. Subsequently, all participants were randomized into 3 groups mouth spray (n = 50), gum (n = 25) and inhaler (n = 25) " and treated for 3 months.
Written and revised by
Andrey Nailor, M.D.
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Fifty-four of the 100 smokers preferred the spray, compared with 28 and 18 who preferred the gum and inhaler, respectively (p < 0.01 for spray vs. both the gum and inhaler). At 6 months, the sustained abstinence rates were 8 (16%), 5 (20%) and 2 (8%) for the mouth spray, gum and inhaler, respectively (p values = n.s.). Adverse effects were mostly drug-related local symptoms, most frequently reported at the end of the tryout period: out of 106 drug-related adverse effects, 90 were due to the spray, 11 and 5 to the inhaler and gum, respectively. The three most frequent adverse effects were almost exclusively caused by the spray: burning of the tongue/throat reported by 35, nausea by 18, and hiccup by 16 participants.
Still, recent smoking-cessation trials combining intensive counseling and medication have come up with better overall numbers. They've suggested that about 25 percent of smokers can be cigarette-free at the one-year mark with medication - whether NRT or the prescription drugs varenicline (Chantix) or bupropion (Zyban and generics) - and strong support.
The lower rate in this study may be due to the "minimal" counseling offered to the trial participants, according to Tonnesen.
"There is an increase in quit rates with the intensity of support (counseling)," he told Reuters Health in an email.
The study involved 479 smokers who were randomly assigned to use the NRT mouth spray or a placebo spray (containing capsaicin to mimic nicotine's burn) for 12 weeks. They also got some brief advice on quitting when they made trips to the study clinics.
All study participants were told to use the spray whenever they would normally have a cigarette, or when they felt a craving for one, but not to exceed four sprays per hour or 64 sprays a day.
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Abstinence was verified by breath and saliva testing.
Both nicotine-spray and placebo users reported reduced cravings over time, and both groups gained weight - averaging 4.9 kg (about 11 lbs) in the nicotine spray group and 4.2 kg (about 9 lbs) in the placebo group by week 24.
Mild-to-moderate side effects reported by both groups, but more often by the nicotine-spray users, included hiccups, throat irritation, nausea, and salivating too much.
Nicotine mouth spray quickly curbs cravings A nicotine mouth spray may help calm cigarette cravings up to three times faster than nicotine lozenges or chewing gum, a study suggests.
This added speed might help recovering smokers avoid powerful urges to light back up.
"The problem with current nicotine replacement therapies is that they just can't compete with smoking," lead researcher Dr. Hayden McRobbie, of The London School of Medicine and Dentistry in the United Kingdom, told Reuters Health. "After taking a puff of a cigarette, you get a hit of nicotine to the brain within around 20 seconds."
The nicotine patch, on the other hand, can take up to three hours to deliver its full effect, he explained. Gum can take a half hour. And while new nasal sprays do work faster - within 10 to 15 minutes - they are reported as very unpleasant to use, McRobbie said.
Meanwhile, studies have shown that increases in cravings appear within just 10 minutes of a smoking relapse. This may partially explain why fewer than one in five of the recovering smokers who use these products are able to stay away from cigarettes long-term, McRobbie noted.
The study was funded by McNeil AB, which makes the Nicorette QuickMist mouth spray. Tonnesen and other researchers on the work have financial ties to McNeil AB and other NRT product makers.
In general, experts recommend NRT products as one option in the battle to quit smoking. But they also stress that many people need a combination of measures, and several different attempts at quitting before they finally succeed.
The American Lung Association (ALA) says that while some smokers can quit "cold turkey," the best bet for most is to try a combination of medication and some type of behavioral counseling.
An example is the ALA's "Freedom From Smoking" program, which is available online (www.ffsonline.org).
And NRT products are no "silver bullet," said Dr. Gregory Connolly, director of the Center for Global Tobacco Control at the Harvard School of Public Health.
In a recent study, Connolly and his colleagues found that in the "real world," NRT products may not be all that effective in the long term. Using several surveys of about 800 smokers, they found that among people who tried to quit over six years, those who used NRT products were just as likely to relapse as those who hadn't used the tactic.
That's not to say that NRT cannot help smokers, Connolly told Reuters Health in an email.
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"I think we are not criticizing such products for their intended use, treatment of withdrawal," Connolly said.
But, he added, "Dependence on tobacco encompasses other factors - factors that exist far longer than nicotine withdrawal and that, over the long term result in relapse."
Smokers who are highly motivated to quit, and get themselves out of the social environment that feeds their habit, may have the best chances of lasting success, according to Connolly.
Even with combination therapies, kicking the smoking habit is often an uphill battle. The ALA estimates that it takes the average smoker five or six serious attempts to finally quit.
And according to the U.S. Department of Health and Human Services, 36 percent of the nation's smokers try to kick the habit each year - but only three percent succeed in quitting for six months or more.
Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double blind trial
P. Tønnesen, H. Lauri, R. Perfekt, K. Mann and A. Batra
Dept of Pulmonary Medicine, Gentofte University Hospital, Copenhagen, Denmark Global Medical Affairs & Clinical Research, McNeil AB, Helsingborg, Sweden Dept of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg, Germany Dept of Psychiatry and Psychotherapy, Section for Addiction Medicine and Research, University Hospital of Tubingen, Germany
P. Tønnesen, Dept of Pulmonary Medicine, Gentofte University Hospital, DK-2900 Hellerup, Denmark, E-mail: philipt@dadlnet.dk
A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy such as a faster uptake of nicotine and faster relief of craving.
This multicentre, randomised (2:1), double blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from Week 2 until Weeks 6, 24, and 52 in 479 smokers (≥ one cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany.
Active treatment yielded significantly higher continuous abstinence rates than placebo from Week 2 until Week 6 (26.1% vs. 16.1%, relative success rate (RR) 1.62, 95% confidence interval (CI), 1.09, 2.41), Week 24 (15.7% vs. 6.8%, RR 2.30, 95%CI, 1.23, 4.30), and Week 52 (13.8% vs. 5.6%, RR 2.48, 95% CI, 1.24, 4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active vs. 71.4% with placebo spray.
Nicotine mouth spray delivered significantly higher 6-, 24-, and 52-Week continuous abstinence rates than placebo.
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