NCT00235313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2007

Enrollment Period

2.1 years

First QC Date

October 6, 2005

Last Update Submit

March 28, 2008

Conditions

Smoking Cessation

Keywords

Nicotine replacement therapiesSmokingSmoking related diseasesSaliva cotinineDose adjustmentSmoker; patients with smoking related disease conditions

Outcome Measures

Primary Outcomes (1)

  • sustained smoking abstinence

    during the study

Secondary Outcomes (1)

  • 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

    during the study

Study Arms (2)

1

EXPERIMENTAL

adaptation of the nicotine patch with salivary cotinine

Procedure: Dose adjustment of nicotine replacement therapies

2

OTHER

normal following with a nicotine patch

Drug: nicotine patch

Interventions

Dose adjustment of nicotine replacement therapiesPROCEDURE

Dose adjustment of nicotine replacement therapies

1
nicotine patchDRUG

normal following with a nicotine patch

Also known as: normal following with a nicotine patch
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smokers whose follow-up during the duration of the study, in a predictable way, cannot be assured.
  • persons under TSN, neuroleptic, substitute treatments in OPINOIDES, under anticoagulants-non-equilibrating,
  • encircled woman
  • breast-feeding woman
  • Contraindication usual of the TSN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique

Paris, 75013, France

Location

Related Publications (4)

  • 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.

    PMID: 7563559BACKGROUND

  • 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.

    PMID: 26160457DERIVED

  • 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.

    PMID: 23623506DERIVED

  • 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.

    PMID: 21205047DERIVED

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yvan BERLIN, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 1, 2008

Record last verified: 2007-03

Locations

FR(1)