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NCT02676375 · ClinicalTrials.gov registry record · Phase 4
Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment
A Phase 4 study, sponsored by Brentwood Biomedical Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT02676375: Completed Phase 4 study, sponsored by Brentwood Biomedical Research Institute.
NCT02676375 is a Phase 4 study that has completed, run by Brentwood Biomedical Research Institute. The registered enrollment target is 42 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
NCT02676375, a Phase 4 study, has completed, sponsored by Brentwood Biomedical Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study Summary
The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.
Primary Outcome
Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).
Interventions
- DRUG Combination Bupropion + NRTs
- OTHER Extended Treatment
- OTHER Home Visits & Calls
- DRUG Monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
What the finished NCT02676375 record still lists
NCT02676375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 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 4 interventions - of which Combination Bupropion + NRTs is the first listed.
NCT02676375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02676375 about?
NCT02676375 is a clinical study titled "Nicotine Receptor Density & Response to Nicotine Patch: Pt 2 Extended Treatment". The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15),...
What is the current status of trial NCT02676375?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2014-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02676375?
The interventions under investigation include: Combination Bupropion + NRTs (DRUG), Extended Treatment (OTHER), Home Visits & Calls (OTHER), Monotherapy (DRUG).
Who is sponsoring clinical trial NCT02676375?
This trial is sponsored by Brentwood Biomedical Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02676375's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 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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