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Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit (ACCESSATION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818207
First received: January 6, 2009
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
Results First Received: February 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Smoking Cessation
Insurance Coverage
Interventions: Other: Full Smoking Cessation Treatment Coverage (100%)
Other: No Smoking Cessation Treatment Coverage (0%)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Reimbursement for Smoking Cessation Therapy (SCT) Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
No Reimbursement for SCT Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.

Participant Flow:   Overall Study
    Reimbursement for Smoking Cessation Therapy (SCT)     No Reimbursement for SCT  
STARTED     696     684  
COMPLETED     474     417  
NOT COMPLETED     222     267  
Adverse Event                 6                 0  
Lost to Follow-up                 160                 146  
Multiple reasons                 11                 12  
Withdrawal by Subject                 42                 104  
Death                 3                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Reimbursement for Smoking Cessation Therapy (SCT) Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
No Reimbursement for SCT Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
Total Total of all reporting groups

Baseline Measures
    Reimbursement for Smoking Cessation Therapy (SCT)     No Reimbursement for SCT     Total  
Number of Participants  
[units: participants]
 		  696     684     1380  
Age  
[units: Years]
Mean ± Standard Deviation 		  46.5  ± 12.3     46.7  ± 12.3     46.6  ± 12.3  
Gender  
[units: Participants]
 		     
Female     342     347     689  
Male     354     337     691  



  Outcome Measures
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1.  Primary:   Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence   [ Time Frame: Week 26 ]
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2.  Secondary:   Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco   [ Time Frame: Week 26 ]
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3.  Secondary:   Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52   [ Time Frame: Week 26, Week 39, and Week 52 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With 7-Day PP of Abstinence at Week 13   [ Time Frame: Week 13 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52   [ Time Frame: Week 26 to Week 52 ]
  Show Outcome Measure 5


  Serious Adverse Events
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Time Frame No text entered.
Additional Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
Reimbursement for Smoking Cessation Therapy (SCT) Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
No Reimbursement for SCT Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.

Serious Adverse Events
    Reimbursement for Smoking Cessation Therapy (SCT)     No Reimbursement for SCT  
Total, serious adverse events      
# participants affected / at risk     35/696 (5.03%)     25/684 (3.65%)  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Cardiac disorders      
Acute coronary syndrome * 1    
# participants affected / at risk     2/696 (0.29%)     0/684 (0.00%)  
Acute myocardial infarction * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Angina unstable * 1    
# participants affected / at risk     1/696 (0.14%)     1/684 (0.15%)  
Atrioventricular block * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Cardiac arrest * 1    
# participants affected / at risk     2/696 (0.29%)     2/684 (0.29%)  
Cardiac failure congestive * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Myocardial infarction * 1    
# participants affected / at risk     1/696 (0.14%)     3/684 (0.44%)  
Myocardial ischaemia * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Endocrine disorders      
Adrenal insufficiency * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Gastrointestinal disorders      
Abdominal pain * 1    
# participants affected / at risk     1/696 (0.14%)     1/684 (0.15%)  
Duodenitis * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Pancreatitis acute * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Hepatobiliary disorders      
Cholecystitis * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Immune system disorders      
Hypersensitivity * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Infections and infestations      
Appendicitis * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Bronchitis * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Lower respiratory tract infection * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Pneumonia * 1    
# participants affected / at risk     2/696 (0.29%)     2/684 (0.29%)  
Post procedural infection * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Vestibular neuronitis * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Viral infection * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Injury, poisoning and procedural complications      
Femur fracture * 1    
# participants affected / at risk     0/696 (0.00%)     2/684 (0.29%)  
Foot fracture * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Gastrointestinal disorder postoperative * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Hip fracture * 1    
# participants affected / at risk     0/696 (0.00%)     2/684 (0.29%)  
Intentional overdose * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Joint dislocation * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Lower limb fracture * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Overdose * 1    
# participants affected / at risk     0/696 (0.00%)     2/684 (0.29%)  
Road traffic accident * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Upper limb fracture * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Investigations      
Weight decreased * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Metabolism and nutrition disorders      
Diabetes mellitus inadequate control * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Hyperglycaemia * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Hyperkalaemia * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Hyponatraemia * 1    
# participants affected / at risk     2/696 (0.29%)     0/684 (0.00%)  
Musculoskeletal and connective tissue disorders      
Muscular weakness * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Colon cancer * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Lung neoplasm malignant * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Metastases to liver * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Metastases to lung * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Prostate cancer * 1    
# participants affected / at risk     1/696 (0.14%)     1/684 (0.15%)  
Thyroid cancer * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Nervous system disorders      
Subarachnoid haemorrhage * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Syncope * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Psychiatric disorders      
Confusional state * 1    
# participants affected / at risk     2/696 (0.29%)     0/684 (0.00%)  
Depression * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Dissociative identity disorder * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Drug abuse * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Major depression * 1    
# participants affected / at risk     1/696 (0.14%)     1/684 (0.15%)  
Suicidal ideation * 1    
# participants affected / at risk     2/696 (0.29%)     0/684 (0.00%)  
Violence-related symptom * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
Renal and urinary disorders      
Nephrolithiasis * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Renal impairment * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Reproductive system and breast disorders      
Haemorrhagic ovarian cyst * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Chronic obstructive pulmonary disease * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Dyspnoea * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Pneumonia aspiration * 1    
# participants affected / at risk     1/696 (0.14%)     0/684 (0.00%)  
Vascular disorders      
Peripheral arterial occlusive disease * 1    
# participants affected / at risk     0/696 (0.00%)     1/684 (0.15%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 13.1




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00818207     History of Changes
Other Study ID Numbers: A3051116
Study First Received: January 6, 2009
Results First Received: February 29, 2012
Last Updated: February 29, 2012
Health Authority: Canada: Ethics Review Committee