Phase 3
Completed N=207
Extended Varenicline Treatment for Smoking Among Cancer Patients
Source: ClinicalTrials.gov NCT01756885 ↗Enrolled (actual)
207
Serious AEs
10.6%
Results posted
Jun 2019
Primary outcomePrimary: 7-day CO-verified Tobacco Abstinence — 28; 32; 16; 17 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day CO-verified Tobacco Abstinence |
28; 32; 16; 17 | — |
| SECONDARY Quality of Life at Week 24 and 52 |
38.75; 38.46; 38.06; 36.91 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average, for the last 6 months.
- Current cancer diagnosis (all sites) or diagnosis within the past 5 years.
- Karnofsky Score of >50 or ECOG Performance Status score of 160 or DBP >100).
a. Note: If a participant presents with blood pressure greater than 160/100 at sessions occurring on Week 0 (Pre-Quit) or at any other point during the treatment period, they will not be provided with/able to continue on medication unless the study physician grants approval.
- History of heart disease, stroke or MI, unstable angina, abnormal heart rhythms, or tachycardia (if stable, requires Study Physician approval).
- Abnormal ECG (unless approved by Study Physician).
- Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or self-reported suicide attempt.
- Current or past diagnosis of psychotic or bipolar disorder, as determined by self-report & MINI.
- Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for >30 days).
- Previous allergic reaction to varenicline.
General Exclusion Criteria
- Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Data sourced from ClinicalTrials.gov (NCT01756885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.