Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

Study Overview
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Brief Summary
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Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.

Detailed Description
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Smokers currently smoking at least 10 cigarettes per day with smoking related diseases are included. They are randomized either to receive standard nicotine replacement therapy (24 h nicotine patch 21, 14, 7 mg/day for one month each, respectively), control arm, or nicotine dose adjustment according their saliva cotinine: dose adaptation arm. In the control arm, at the discretion of the investigators, buccal forms of nicotine replacement therapies are allowed. In both arms, saliva cotinine determinations are performed every 2 weeks for 2 months. In the control arm saliva cotinine results are not communicated to the investigators. In the dose adaptation arm investigators receive saliva cotinine results and should adapt the nicotine doses (mg of nicotine/day) according to baseline (when smoking) saliva cotinine to obtain 100 % substitution. Smokers are assessed at weekly visits after the predetermined quit day for 3 months. Follow up at 6 months. Main outcome measure: sustained abstinence (self reported no smoking and expired air carbon monoxide concentration equal or less than 8 ppm during the last (3rd) month of the treatment phase.

Official Title
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Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?

Conditions
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Smoking Cessation

Intervention / Treatment
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* Procedure: Dose adjustment of nicotine replacement therapies
* Drug: nicotine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Smoking ≥ 10 cigarettes per day Patients with disease conditions known to be related to smoking: e.g.coronary heart diseases, COPD, lower extremity arterial disease, etc Exclusion Criteria: Smokers whose follow-up during the duration of the study, in a predictable way, cannot be assured. smokers having been treated by bupropion ( Zyban) during two months preceding the inclusion persons under TSN, neuroleptic, substitute treatments in OPINOIDES, under anticoagulants-non-equilibrating, encircled woman breast-feeding woman Contraindication usual of the TSN

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>adaptation of the nicotine patch with salivary cotinine | Procedure: Dose adjustment of nicotine replacement therapies<br>* Dose adjustment of nicotine replacement therapies<br>|
| Other: 2<br>normal following with a nicotine patch | Drug: nicotine patch<br>* normal following with a nicotine patch<br>* Other names: normal following with a nicotine patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained smoking abstinence |  | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| point prevalence abstinence,craving for tobacco,symptoms of nicotine withdrawal,weight,saliva cotinine concentration,genetic polymorphisms as predictors of therapeutic response and in interaction with nicotine replacement therapies |  | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine replacement therapies, Smoking, Smoking related diseases, Saliva cotinine, Dose adjustment, Smoker; patients with smoking related disease conditions