Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

Smoking Cessation Clinical Trial

— ADONIS  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235313
• Other study ID #: P040406
• Secondary ID: AOR04001
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2005
• Last updated: March 28, 2008
• Start date: October 2005
• Est. completion date: November 2007

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Procedure:
• Dose adjustment of nicotine replacement therapies
Dose adjustment of nicotine replacement therapies

Drug:
• nicotine patch
normal following with a nicotine patch

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	French Health Products Safety Agency

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained smoking abstinence		during the study	Yes
Secondary	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	Yes