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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
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.
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
Monthly brief (10-15 minutes) meetings with medical staff.
University of California San Francisco
San Francisco, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
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.
Time frame: 104 weeks following treatment initiation
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.
Time frame: 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.
Time frame: 52 weeks following treatment initiation