Phase 4
Completed N=1,380
Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit
Smoking Cessation · Insurance Coverage
Source: ClinicalTrials.gov NCT00818207 ↗
Enrolled (actual)
1,380
Serious AEs
4.4%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence — 20.8; 13.9 Percentage of Participants — p=0.0007
Summary
This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence |
20.8; 13.9 | 0.0007 sig |
| SECONDARY Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco |
15.7; 10.1 | 0.0018 sig |
| SECONDARY Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52 |
15.7; 10.1; 7.8; 6.3; 6.6; 5.6 | 0.2979 |
| SECONDARY Percentage of Participants With 7-Day PP of Abstinence at Week 13 |
34.1; 23.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52 |
20.8; 13.9; 19.7; 12.6; 17.4; 12.3 | 0.4551 |
Eligibility Criteria
Inclusion Criteria
- Daily smokers (10 cigarettes per day or more);
- Smokers motivated to make a quit attempt within the next 14 days;
- Potential subjects must be outpatients;
- A subject must have a stable mental and physical medical condition (as per investigator's judgment).
Exclusion Criteria
- A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;
- A subject with an unknown drug insurance status;
- A subject living in a household where there is someone already recruited in the study;
- A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product;
- A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).
Data sourced from ClinicalTrials.gov (NCT00818207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.