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NCT01756885 · ClinicalTrials.gov registry record · Phase 3
Extended Varenicline Treatment for Smoking Among Cancer Patients
A Phase 3 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 207
- Enrollment target
NCT01756885: Completed Phase 3 study, sponsored by University of Pennsylvania.
NCT01756885 is a Phase 3 study that has completed, run by University of Pennsylvania. The registered enrollment target is 207 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756885, a Phase 3 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 207 participants
- Enrollment target
Study Summary
Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. With medical advances in cancer care yielding a growing constituency of cancer survivors, addressing nicotine dependence in this population is a priority. While PHS guidelines recommend acute treatment durations with approved medications for tobacco use, extending the duration of treatment beyond the standard treatment duration significantly increases quit rates, reduces the risk for a relapse, and promotes recovery to abstinence following a lapse. Varenicline may be particularly effective for cancer patients given the drug's beneficial effects on affect and cognition. In this trial, 374 cancer patients will be randomized to standard varenicline treatment (12 weeks active + 12 weeks placebo) or extended varenicline treatment (24 weeks active). The investigators hypothesize that 1) Extended varenicline therapy will increase 24- and 52-week biochemically-confirmed abstinence versus standard varenicline treatment, 2) Quality of life will be rated higher in the extended therapy group versus the standard therapy group, and there will be no significant differences between groups in terms of severe side effects, and 3) Improved affect and reduced cognitive impairment will mediate the effect of extended therapy on quit rates.
Interventions
- DRUG Placebo
- DRUG Varenicline
- BEHAVIORAL Smoking Cessation Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01756885
The ClinicalTrials.gov registry entry for NCT01756885 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01756885 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01756885 about?
NCT01756885 is a clinical study titled "Extended Varenicline Treatment for Smoking Among Cancer Patients". Upwards of 33-50% of cancer patients who smoked prior to diagnosis continue to smoke following diagnosis and treatment. With medical advances in cancer care yielding a growing constituency of cancer survivors, addressing nicotine dependence in this population is a priority. While PHS guidelines reco...
What is the current status of trial NCT01756885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 207 participants. The study started on 2013-01. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT01756885?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG), Smoking Cessation Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01756885?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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