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Maintaining Nonsmoking
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.
Details
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 216 |
| Start date | 2010-05 |
| Completion | 2016-06 |
Conditions
- Nicotine Dependence
Interventions
- Varenicline
- Initial Individual counseling
- Check-ins with medical staff
- Extended Individual Counseling - Health Model
- Extended Individual Counseling - Relapse Prevention Model
Primary outcomes
- 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 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. - 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.
Countries
United States