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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
  Purpose

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 Intervention Phase
Smoking Cessation
 Procedure: Dose adjustment of nicotine replacement therapies
Drug: nicotine patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 300
Study Start Date: October 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
adaptation of the nicotine patch with salivary cotinine
 Procedure: Dose adjustment of nicotine replacement therapies
Dose adjustment of nicotine replacement therapies
Other Name: Dose adjustment of nicotine replacement therapies
2
normal following with a nicotine patch
 Drug: nicotine patch
normal following with a nicotine patch
Other Name: normal following with a nicotine patch

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235313

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christophe AUCAN, Department of Clinical Trial of Developpement
ClinicalTrials.gov Identifier: NCT00235313     History of Changes
Other Study ID Numbers: P040406, AOR04001
Study First Received: October 6, 2005
Last Updated: March 28, 2008
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nicotine replacement therapies
Smoking
Smoking related diseases
 Saliva cotinine
Dose adjustment
Smoker; patients with smoking related disease conditions

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013