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Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS trial—a randomized study in smokers with medical comorbidities

Identifieur interne : 002769 ( Main/Exploration ); précédent : 002768; suivant : 002770

Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS trial—a randomized study in smokers with medical comorbidities

Auteurs : Ivan Berlin [France] ; Nelly Jacob [France] ; Mathieu Coudert [France] ; Jean Perriot [France] ; Laurette Schultz [France] ; Nicolas Rodon [France]

Source :

RBID : ISTEX:31F356B4E8AED4F9204FAE704142751A15650BD7

English descriptors

Abstract

Aims  To assess the efficacy of nicotine replacement therapies (NRT) when the daily dose was adapted according to saliva cotinine concentrations.
Design  Randomized, multi‐centre, single‐blind, controlled trial.
Setting  Twenty‐one smoking cessation clinics in France.
Participants  A total of 310 smokers with medical comorbidities, motivated to quit, smoking ≥10 cigarettes/day, for whom smoking cessation was mandatory. NRT was administered for 3 months. The standard care group received nicotine patches with monthly dose decreases; buccal absorption NRT could be co‐administered at the discretion of the investigator. In the dose adaptation group, the aim was a 100 ± 5% nicotine substitution with respect to smoking state based on the determination of saliva cotinine concentrations. NRT daily doses were prescribed according to the previous week's saliva cotinine concentrations in the dose adaptation group; saliva cotinine concentrations were not provided in the standard care group.
Measurements  Prolonged abstinence rate (weeks 9–12, main outcome measure), point‐prevalence and continuous abstinence rate, saliva cotinine concentration, NRT daily dose, craving for cigarettes.
Findings  The median daily prescribed NRT dose was 30 and 31 mg/day in the first study week and 17.25 and 35.5 mg/day during weeks 9–12 in the standard care group and dose adaptation group, respectively. Saliva cotinine remained stable in the dose adaptation group and decreased in the standard care group (P < 0.01) by weeks 9–12. The cotinine substitution rate was significantly lower in the standard care group than in the dose adaptation group. Despite differences in NRT doses and cotinine substitution rates, prolonged (standard care group: 26.4%, dose adaptation group: 30.3%), continuous (standard care group: 8%, dose adaptation group: 12%) and point‐prevalence abstinence rates were similar.
Conclusions  In smokers with medical comorbidities and highly motivated to quit, adaptation of the nicotine replacement therapy daily dose according to saliva cotinine does not appear to be substantially superior to standard nicotine replacement therapy use.

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DOI: 10.1111/j.1360-0443.2010.03306.x


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<term>Abstinence</term>
<term>Abstinence rate</term>
<term>Abstinence rates</term>
<term>Abstinent</term>
<term>Abstinent smokers</term>
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<term>Adverse effect</term>
<term>Adverse effects</term>
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<term>Baseline saliva cotinine concentration</term>
<term>Buccal</term>
<term>Buccal absorption</term>
<term>Cardiovascular disease</term>
<term>Centre</term>
<term>Centre hospitalier</term>
<term>Centre hospitalier universitaire</term>
<term>Cessation</term>
<term>Clinical assessment</term>
<term>Comorbidities</term>
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<term>Cotinine</term>
<term>Cotinine substitution rate</term>
<term>Counselling</term>
<term>Daily dose</term>
<term>Daily doses</term>
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<term>Dose</term>
<term>Dose adaptation</term>
<term>Dose adaptation group</term>
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<term>Ivan berlin</term>
<term>Laboratoire pierre fabre sant</term>
<term>Median</term>
<term>Medical comorbidities</term>
<term>More participants</term>
<term>Nicotine</term>
<term>Nicotine dependence</term>
<term>Nicotine intake</term>
<term>Nicotine patch</term>
<term>Nicotine patches</term>
<term>Nicotine replacement therapies</term>
<term>Nicotine replacement therapy</term>
<term>Nicotine substitution</term>
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<term>Previous history</term>
<term>Pulmonary disease</term>
<term>Randomization</term>
<term>Randomized</term>
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<term>Saliva cotinine</term>
<term>Saliva cotinine concentration</term>
<term>Saliva cotinine concentrations</term>
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<term>Smoking</term>
<term>Smoking cessation</term>
<term>Smoking state</term>
<term>Standard care</term>
<term>Standard care group</term>
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<front>
<div type="abstract">Aims  To assess the efficacy of nicotine replacement therapies (NRT) when the daily dose was adapted according to saliva cotinine concentrations.</div>
<div type="abstract">Design  Randomized, multi‐centre, single‐blind, controlled trial.</div>
<div type="abstract">Setting  Twenty‐one smoking cessation clinics in France.</div>
<div type="abstract">Participants  A total of 310 smokers with medical comorbidities, motivated to quit, smoking ≥10 cigarettes/day, for whom smoking cessation was mandatory. NRT was administered for 3 months. The standard care group received nicotine patches with monthly dose decreases; buccal absorption NRT could be co‐administered at the discretion of the investigator. In the dose adaptation group, the aim was a 100 ± 5% nicotine substitution with respect to smoking state based on the determination of saliva cotinine concentrations. NRT daily doses were prescribed according to the previous week's saliva cotinine concentrations in the dose adaptation group; saliva cotinine concentrations were not provided in the standard care group.</div>
<div type="abstract">Measurements  Prolonged abstinence rate (weeks 9–12, main outcome measure), point‐prevalence and continuous abstinence rate, saliva cotinine concentration, NRT daily dose, craving for cigarettes.</div>
<div type="abstract">Findings  The median daily prescribed NRT dose was 30 and 31 mg/day in the first study week and 17.25 and 35.5 mg/day during weeks 9–12 in the standard care group and dose adaptation group, respectively. Saliva cotinine remained stable in the dose adaptation group and decreased in the standard care group (P < 0.01) by weeks 9–12. The cotinine substitution rate was significantly lower in the standard care group than in the dose adaptation group. Despite differences in NRT doses and cotinine substitution rates, prolonged (standard care group: 26.4%, dose adaptation group: 30.3%), continuous (standard care group: 8%, dose adaptation group: 12%) and point‐prevalence abstinence rates were similar.</div>
<div type="abstract">Conclusions  In smokers with medical comorbidities and highly motivated to quit, adaptation of the nicotine replacement therapy daily dose according to saliva cotinine does not appear to be substantially superior to standard nicotine replacement therapy use.</div>
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<name sortKey="Berlin, Ivan" sort="Berlin, Ivan" uniqKey="Berlin I" first="Ivan" last="Berlin">Ivan Berlin</name>
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<name sortKey="Berlin, Ivan" sort="Berlin, Ivan" uniqKey="Berlin I" first="Ivan" last="Berlin">Ivan Berlin</name>
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<name sortKey="Perriot, Jean" sort="Perriot, Jean" uniqKey="Perriot J" first="Jean" last="Perriot">Jean Perriot</name>
<name sortKey="Rodon, Nicolas" sort="Rodon, Nicolas" uniqKey="Rodon N" first="Nicolas" last="Rodon">Nicolas Rodon</name>
<name sortKey="Schultz, Laurette" sort="Schultz, Laurette" uniqKey="Schultz L" first="Laurette" last="Schultz">Laurette Schultz</name>
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