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Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS) - Article


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Nicotine Gum

Nicorette; Nicotine polacrilex 



Clinical Trial: Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

This study is not yet open for patient recruitment.
Verified by Assistance Publique - Hôpitaux de Paris April 2005

Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
Agence Française de Sécurité Sanitaire et des Produits de Santé (AFSSAPS)
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00235313

Purpose

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.
Condition Intervention Phase
Smoking Cessation
  Procedure: Dose adjustment of nicotine replacement therapies
 Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Official Title: L’Adaptation Posologique Des Traitements Substitutifs Nicotiniques Sur La Cotinine Salivaire améliore-t-Elle l’efficacité De Ces Traitements d’Aide Au Sevrage Tabagique Des Patients à Haut Risque? Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments in Patients at High Risks of Mortality?

Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcomes: sustained smoking abstinence
Secondary Outcomes: 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
Expected Total Enrollment:  300

Study start: November 2005;  Expected completion: December 2007
Last follow-up: June 2007

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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:

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00235313

Yvan BERLIN, MD, PhD      +33(0)-1 42 16 16 78    ivan.berlin@psl.aphp.fr

France
      Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique, Paris,  75013,  France
Yvan BERLIN, MD,PhD  +33(0)-1 42 16 16 78    ivan.berlin@psl.aphp.fr 

Study chairs or principal investigators

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

More Information

Publications

Dale LC, Hurt RD, Offord KP, Lawson GM, Croghan IT, Schroeder DR. High-dose nicotine patch therapy. Percentage of replacement and smoking cessation. JAMA. 1995 Nov 1;274(17):1353-8.

Study ID Numbers:  P040406; AOR04001
Last Updated:  December 8, 2005
Record first received:  October 6, 2005
ClinicalTrials.gov Identifier:  NCT00235313
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006

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Page Updated: June 1, 2005
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