A Phase 4 interventional study of Dose adjustment of nicotine replacement therapies and nicotine patch in Smoking Cessation, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-01.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
adaptation of the nicotine patch with salivary cotinine
Procedure: Dose adjustment of nicotine replacement therapies
normal following with a nicotine patch
Drug: nicotine patch
Dose adjustment of nicotine replacement therapies
normal following with a nicotine patch
Also known as: normal following with a nicotine patch
sustained smoking abstinence
Time frame: during the study
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
Time frame: during the study
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris