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NCT01162239 · ClinicalTrials.gov registry record · Phase 3
Maintaining Nonsmoking
A Phase 3 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT01162239: Completed Phase 3 study, sponsored by University of California, San Francisco.
NCT01162239 is a Phase 3 study that has completed, run by University of California, San Francisco. The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162239, a Phase 3 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study 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.
Primary Outcome
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.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01162239 record still lists
NCT01162239 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Varenicline is the first listed.
NCT01162239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01162239 about?
NCT01162239 is a clinical study titled "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, i...
What is the current status of trial NCT01162239?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2010-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01162239?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01162239?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01162239's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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