Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

This study has been completed.

Sponsor:

Collaborator:

French Health Products Safety Agency

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00235313

First received: October 6, 2005

Last updated: March 28, 2008

Last verified: March 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2005

Last Updated Date

March 28, 2008

Start Date ^ICMJE

October 2005

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

sustained smoking abstinence [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

sustained smoking abstinence

Change History

Complete list of historical versions of study NCT00235313 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

Official Title ^ICMJE

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?

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Procedure: Dose adjustment of nicotine replacement therapies
Dose adjustment of nicotine replacement therapies

Other Name: Dose adjustment of nicotine replacement therapies
Drug: nicotine patch
normal following with a nicotine patch

Other Name: normal following with a nicotine patch

Study Arm (s)

Experimental: 1
adaptation of the nicotine patch with salivary cotinine

Intervention: Procedure: Dose adjustment of nicotine replacement therapies
2
normal following with a nicotine patch

Intervention: Drug: nicotine patch

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00235313

Other Study ID Numbers ^ICMJE

P040406, AOR04001

Has Data Monitoring Committee

Yes

Responsible Party

Christophe AUCAN, Department of Clinical Trial of Developpement

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

French Health Products Safety Agency

Investigators ^ICMJE

Principal Investigator:

Yvan BERLIN, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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