Official Title: “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?”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2007

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.

Intervention(s) in this Clinical Trial

• Procedure: Dose adjustment of nicotine replacement therapies
  • Dose adjustment of nicotine replacement therapies
• Drug: nicotine patch
  • normal following with a nicotine patch

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • adaptation of the nicotine patch with salivary cotinine
• Other: 2
  • normal following with a nicotine patch

Primary Measures

• sustained smoking abstinence
  • Time Frame: during the study
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

Yvan BERLIN, MD,PhD Principal Investigator Assistance Publique - Hôpitaux de Paris  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00235313

Study ID Number: P040406

ClinicalTrials.gov Identifier: NCT00235313

Health Authority: France: Ministry of Health

Summary of the study protocol