Status:
COMPLETED
Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
French Health Products Safety Agency
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00235313
Start Date
October 1 2005
End Date
November 1 2007
Last Update
April 1 2008
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique
Paris, France, 75013