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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235313
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : April 1, 2008
French Health Products Safety Agency
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Procedure: Dose adjustment of nicotine replacement therapies Drug: nicotine patch Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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?
Study Start Date : October 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
adaptation of the nicotine patch with salivary cotinine
Procedure: Dose adjustment of nicotine replacement therapies
Dose adjustment of nicotine replacement therapies

normal following with a nicotine patch
Drug: nicotine patch
normal following with a nicotine patch
Other Name: normal following with a nicotine patch

Primary Outcome Measures :
  1. sustained smoking abstinence [ Time Frame: during the study ]

Secondary Outcome Measures :
  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 [ Time Frame: during the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235313

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Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
French Health Products Safety Agency
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Principal Investigator: Yvan BERLIN, MD,PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christophe AUCAN, Department of Clinical Trial of Developpement Identifier: NCT00235313     History of Changes
Other Study ID Numbers: P040406
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nicotine replacement therapies
Smoking related diseases
Saliva cotinine
Dose adjustment
Smoker; patients with smoking related disease conditions
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action