- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00235313
Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS) (ADONIS)
March 28, 2008 updated by: Assistance Publique - Hôpitaux de Paris
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75013
- Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
adaptation of the nicotine patch with salivary cotinine
|
Dose adjustment of nicotine replacement therapies
|
Other: 2
normal following with a nicotine patch
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normal following with a nicotine patch
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sustained smoking abstinence
Time Frame: during the study
|
during the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yvan BERLIN, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
October 6, 2005
First Submitted That Met QC Criteria
October 6, 2005
First Posted (Estimate)
October 10, 2005
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 28, 2008
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P040406
- AOR04001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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