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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 is a Phase 4 study that has completed, run by Brentwood Biomedical Research Institute. The registered enrollment target is 42 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02676375
The ClinicalTrials.gov registry entry for NCT02676375 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brentwood Biomedical Research Institute, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Combination Bupropion + NRTs is the first listed.
NCT02676375 reports 0 study locations.
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.
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