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NCT04011280 · ClinicalTrials.gov registry record · Phase 4
Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 39
- Enrollment target
NCT04011280: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT04011280 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 39 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04011280, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 39 participants
- Enrollment target
Study Summary
Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.
Primary Outcome
Demand for participating (# of participants recruited per month); practicality of study procedures (% participants completing study procedures); acceptability of study procedures (% participants adhering to making a quit attempt within the quit window)
Interventions
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 4 |
What the finished NCT04011280 record still lists
NCT04011280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Varenicline is the first listed.
NCT04011280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04011280 about?
NCT04011280 is a clinical study titled "Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness". Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration s...
What is the current status of trial NCT04011280?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2019-08-12. Estimated completion is 2022-03-04.
What interventions are being tested in trial NCT04011280?
The interventions under investigation include: Varenicline (DRUG).
Who is sponsoring clinical trial NCT04011280?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04011280's enrollment target sits among peer trials
39 1468th of 2000 higher than 525 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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