Maintaining Nonsmoking

Phase 3

Completed

Conditions: Nicotine Dependence

Interventions: 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

Registration Number: NCT01162239

Lead Sponsor: University of California, San Francisco

Brief Summary: 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: 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

1. Monthly Brief Contact or

2. Extended Non-Specific Behavioral Treatment or

3. Extended Relapse Prevention Treatment or

4. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 216

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended Brief Contact	Initial Individual counseling	Following standard brief treatment, participants have monthly meetings with medical staff.
Extended Brief Contact	Varenicline	Following standard brief treatment, participants have monthly meetings with medical staff.
Extended Health Education	Varenicline	Following standard treatment, participants receive monthly counseling with content based on a health education model.
Extended Brief Contact	Check-ins with medical staff	Following standard brief treatment, participants have monthly meetings with medical staff.
Extended Health Education	Initial Individual counseling	Following standard treatment, participants receive monthly counseling with content based on a health education model.
Extended Health Education	Extended Individual Counseling - Health Model	Following standard treatment, participants receive monthly counseling with content based on a health education model.
Extended Relapse Prevention plus varenicline	Varenicline	Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Extended Relapse Prevention plus varenicline	Initial Individual counseling	Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Extended Relapse Prevention plus varenicline	Extended Individual Counseling - Relapse Prevention Model	Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Extended Relapse Prevention	Initial Individual counseling	Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Extended Relapse Prevention	Extended Individual Counseling - Relapse Prevention Model	Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Extended Relapse Prevention	Varenicline	Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12	12 weeks following treatment initiation	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.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64	64 weeks following treatment initiation	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.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104	104 weeks following treatment initiation	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.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24	24 weeks following treatment initiation	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.
Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52	52 weeks following treatment initiation	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Combined Extended vs Brief Treatment at Week 24	24 weeks following treatment initiation	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.
Comparison of Combined Extended vs Brief Treatment at Week 52	52 weeks following treatment initiation	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.