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Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

NCT ID: NCT00235313

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-11-30

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.

Conditions

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Smoking Cessation

Keywords

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Nicotine replacement therapies Smoking Smoking related diseases Saliva cotinine Dose adjustment Smoker; patients with smoking related disease conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

adaptation of the nicotine patch with salivary cotinine

Group Type EXPERIMENTAL

Dose adjustment of nicotine replacement therapies

Intervention Type PROCEDURE

Dose adjustment of nicotine replacement therapies

2

normal following with a nicotine patch

Group Type OTHER

nicotine patch

Intervention Type DRUG

normal following with a nicotine patch

Interventions

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Dose adjustment of nicotine replacement therapies

Dose adjustment of nicotine replacement therapies

Intervention Type PROCEDURE

nicotine patch

normal following with a nicotine patch

Intervention Type DRUG

Other Intervention Names

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normal following with a nicotine patch

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Health Products Safety Agency

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Trial of Developpement

Principal Investigators

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Yvan BERLIN, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 7563559 (View on PubMed)

Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.

Reference Type DERIVED
PMID: 26160457 (View on PubMed)

Berlin I, Singleton EG, Heishman SJ. Predicting smoking relapse with a multidimensional versus a single-item tobacco craving measure. Drug Alcohol Depend. 2013 Oct 1;132(3):513-20. doi: 10.1016/j.drugalcdep.2013.03.017. Epub 2013 Apr 23.

Reference Type DERIVED
PMID: 23623506 (View on PubMed)

Berlin I, Jacob N, Coudert M, Perriot J, Schultz L, Rodon N. Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial-a randomized study in smokers with medical comorbidities. Addiction. 2011 Apr;106(4):833-43. doi: 10.1111/j.1360-0443.2010.03306.x. Epub 2011 Feb 14.

Reference Type DERIVED
PMID: 21205047 (View on PubMed)

Other Identifiers

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AOR04001

Identifier Type: -

Identifier Source: secondary_id

P040406

Identifier Type: -

Identifier Source: org_study_id