Phase 3
N=216
Maintaining Nonsmoking
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01162239 ↗Enrolled (actual)
216
Serious AEs
3.2%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 — 22; 20; 29; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Varenicline (Drug); Initial Individual counseling (Behavioral); Check-ins with medical staff (Behavioral); Extended Individual Counseling - Health Model (Behavioral); Extended Individual Counseling - Relapse Prevention Model (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 |
22; 20; 29; 20 | — |
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 |
20; 18; 24; 21 | — |
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 |
19; 15; 23; 17 | — |
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 |
16; 18; 24; 13 | — |
| PRIMARY Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 |
16; 13; 16; 13 | — |
| SECONDARY Comparison of Combined Extended vs Brief Treatment at Week 24 |
20; 63 | 0.62 |
| SECONDARY Comparison of Combined Extended vs Brief Treatment at Week 52 |
19; 55 | 0.91 |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01162239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.