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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 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 39 participants.
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.
Interventions
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04011280
The ClinicalTrials.gov registry entry for NCT04011280 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Varenicline is the first listed.
NCT04011280 reports 0 study locations.
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.
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