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NCT02582008 · ClinicalTrials.gov registry record · Early Phase 1
Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
NCT02582008: Clinical Trial Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT02582008 is a Early Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 9 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02582008, a Early Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This pilot randomized clinical trial studies how well bupropion hydrochloride works compared with patient's choice for quitting smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may help patients quit smoking by enhancing central nervous system neurotransmitters noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride is more effective than patient's choice in helping quit smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy.
Primary Outcome
Observed rates of patients who are not smoking at 12 months and corresponding 95% exact Clopper-Pearson confidence intervals will be estimated. Next, will perform a Fisher's exact test to determine whether the proportion of patients who are not smoking at 12 months post-RT/CRT in the bupropion hydrochloride group and the patient's choice group are different.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Nicotine Replacement
- DRUG Bupropion Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-09-06 |
| Phase | Early Phase 1 |
Why NCT02582008 stopped before completion
NCT02582008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02582008 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02582008 about?
NCT02582008 is a clinical study titled "Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy". This pilot randomized clinical trial studies how well bupropion hydrochloride works compared with patient's choice for quitting smoking in patients with squamous cell head and neck cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may help patients quit smokin...
What is the current status of trial NCT02582008?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2016-01. Estimated completion is 2019-09-06.
What interventions are being tested in trial NCT02582008?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Nicotine Replacement (DRUG), Bupropion Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02582008?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02582008's enrollment target sits among peer trials
9 1745th of 2000 higher than 219 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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