Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235313
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2005-10-06
Brief Title:
Adjustment of DOses of NIcotine in Smoking Cessation ADONIS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADONIS
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 nicotines main metabolite cotinine improve their efficacy compared with the lack of dose adjustment usual care in smoking patients with smoking related disease condition
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 mgday 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 nicotineday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOR04001 | None | None | None |