Phase 4
Completed N=525
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Source: ClinicalTrials.gov NCT01078298 ↗Enrolled (actual)
525
Serious AEs
2.7%
Results posted
Apr 2013
Primary outcomePrimary: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) — 35.9; 15.6 Percentage of participants — p=<0.0001
Summary
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) |
35.9; 15.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Continuous Abstinence Rate (CAR) |
25.0; 12.3; 20.3; 10.4 | 0.0001 sig |
| SECONDARY Number of Participants With 7-day Point Prevalence (PP) of Abstinence |
118; 54; 80; 49; 73; 47 | <0.0001 sig |
| SECONDARY Number of Participants With 4-Week Point Prevalence (PP) of Abstinence |
70; 45 | 0.0027 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
- Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening
- Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
- On stable antidepressant treatment for MDD (stable dose for at least 2 months)
- Major depressive episode, using DSM IV TR, in the past 2 years successfully treated
Exclusion Criteria
- Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
- Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
- Current use of either bupropion or nortryptiline.
Data sourced from ClinicalTrials.gov (NCT01078298). 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.