Maintaining Nonsmoking

Study Overview
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Brief Summary
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The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.

Detailed Description
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This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols Monthly Brief Contact or Extended Non-Specific Behavioral Treatment or Extended Relapse Prevention Treatment or Extended Relapse Prevention Treatment + availability of varenicline treatment. Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment. All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.

Official Title
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Maintaining Nonsmoking

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Varenicline
* Behavioral: Initial Individual counseling
* Behavioral: Check-ins with medical staff
* Behavioral: Extended Individual Counseling - Health Model
* Behavioral: Extended Individual Counseling - Relapse Prevention Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Must be smoking 5 or more cigarettes per day Exclusion Criteria: Previous history of bipolar/manic-depressive disorder Current diagnosis of schizophrenia Acute life threatening diseases Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol Pregnancy or lactation Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Brief Contact<br>Following standard brief treatment, participants have monthly meetings with medical staff. | Drug: Varenicline<br>* All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.<br>* Other names: Chantix;Behavioral: Initial Individual counseling<br>* Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.<br>Behavioral: Check-ins with medical staff<br>* Monthly brief (10-15 minutes) meetings with medical staff.<br>|
| Experimental: Extended Health Education<br>Following standard treatment, participants receive monthly counseling with content based on a health education model. | Drug: Varenicline<br>* All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.<br>* Other names: Chantix;Behavioral: Initial Individual counseling<br>* Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.<br>Behavioral: Extended Individual Counseling - Health Model<br>* Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.<br>|
| Experimental: Extended Relapse Prevention plus varenicline<br>Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. | Drug: Varenicline<br>* All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.<br>* Other names: Chantix;Behavioral: Initial Individual counseling<br>* Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.<br>Behavioral: Extended Individual Counseling - Relapse Prevention Model<br>* Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.<br>|
| Experimental: Extended Relapse Prevention<br>Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. | Drug: Varenicline<br>* All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.<br>* Other names: Chantix;Behavioral: Initial Individual counseling<br>* Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.<br>Behavioral: Extended Individual Counseling - Relapse Prevention Model<br>* Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 12 weeks following treatment initiation | 
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 24 weeks following treatment initiation | 
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 52 weeks following treatment initiation | 
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 64 weeks following treatment initiation | 
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 104 weeks following treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Combined Extended vs Brief Treatment at Week 24 | The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. | 24 weeks following treatment initiation | 
| Comparison of Combined Extended vs Brief Treatment at Week 52 | The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. | 52 weeks following treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Tobacco, Nicotine, Smoking cessation