Table 1.
Participant Characteristics and Study Outcomes
| ITT | Completers | |||
|---|---|---|---|---|
| Zonisamide + varenicline ( N = 34) | Placebo + varenicline ( N = 40) | Zonisamide + varenicline ( N = 18) | Placebo + varenicline ( N = 27) | |
| Participant characteristics | ||||
| Age (y) | 45.3±9.8 | 45.9±9.7 | 46.8±9.4 | 46.6±10.3 |
| Male (%) | 76.5 | 67.5 | 72.2 | 66.7 |
| Caucasian (%) | 32.4 | 32.5 | 22.2 | 33.3 |
| Hispanic (%) | 0.0 | 2.5 | 0.0 | 3.7 |
| Employed (%) | 44.1 | 32.5 | 44.4 | 29.6 |
| Cigarettes per day (past 30 days) | 17.2±6.3 | 19.5±8.3 | 17.3±3.6 | 20.5±9.2 |
| Years smoked > 10 cigarettes per day | 13.7±10.5 | 18.2±12.9 | 13.0±10.6 | 19.3±14.0 |
| Previous serious quit attempt (%) | 73.5 | 82.5 | 77.8 | 88.9 |
| Study outcomes | ||||
| Smoking related outcomes a | ||||
| Abstinent weeks 7–10 (%) | 14.7 | 15.0 | 27.8 | 22.2 |
| Longest duration continuous abstinence (wk) b | 1.79±2.9 | 2.03±3.06 | 2.83±3.43 | 2.70±3.35 |
| Total visits attended (range 0–10) | 8.3±3.5 | 9.0±3.1 | 10.0 | 10.0 |
| Believed they were receiving zonisamide (% visits) | 54.9 | 52.6 | 54.5 | 49.3 |
| Medication adherence | ||||
| Mean percent adherence (assessed via pill count) (%) | ||||
| Varenicline | 76.7 | 59.8 | 76.1 | 77.0 |
| Study capsules | 73.3 | 73.0 | 84.7 | 86.4 |
| Urine testing confirmation of adherence (%) c | ||||
| Varenicline | 90.3 | 84.6 | 81.3 | 92.6 |
| Zonisamide | 100.0 | n/a | 100.0 | n/a |
No significant between-group comparisons within the intent-to-treat (ITT) and completer analyses; P values not shown values represent mean ± SD unless otherwise noted.
a Smoking outcomes based on urinary cotinine testing.
b Assessed as missing = positive only.
c Point prevalence testing at week 7.