Table 5.
Treatment Outcomes: Differences between Placebo and Varenicline during the Last Month of Treatment (Weeks 3– 6)
| Placebo (n = 23) |
Varenicline ( n = 22) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| LSMEAN | SE | 95% CI | LSMEAN | SE | 95% CI | LSMEAN Δ | SE | d | p | |
| Drinking Outcomes | ||||||||||
| % HDD | 21.0 | 4.9 | 11.1 – 30.9 | 30.7 | 5.0 | 20.7 – 40.7 | 9.7 | 7.0 | 0.09 | 0.262 |
| % days abstinent | 54.2 | 6.4 | 41.4 – 67.1 | 48.6 | 6.4 | 35.6 – 61.6 | −5.6 | 9.1 | −0.01 | 0.543 |
| Drinks per day | 2.5 | 0.5 | 1.4 – 3.5 | 3.7 | 0.5 | 2.6 – 4.7 | 1.2 | 0.8 | 0.49 | 0.205 |
| Drinks per drinking day | 4.0 | 0.8 | 2.4 – 5.6 | 6.8 | 0.8 | 5.2 – 8.3 | 2.8 | 1.1 | 0.48 | 0.061 |
| % | n | denom | % | n | denom | % Δ | aOR (95% CI) | p | ||
| % subjects with no HDD | 30.4 | 7 | 23 | 27.3 | 6 | 22 | −3.1 | 0.83 (0.22–3.17) | 0.790 | |
| % subjects abstinent | 17.4 | 4 | 23 | 9.1 | 2 | 22 | −8.3 | 0.45 (0.07–2.95) | 0.405 | |
| WHO 1-shift reduction | 82.6 | 19 | 23 | 63.6 | 14 | 22 | −19.0 | 0.35 (0.08–1.43) | 0.148 | |
| WHO 2-shift reduction | 60.9 | 14 | 23 | 40.9 | 9 | 22 | −20.0 | 0.44 (0.13–1.47) | 0.182 | |
| % subjects with very HDD | 34.8 | 8 | 23 | 63.6 | 14 | 22 | 28.8 | 4.32(1.13–16.51) | 0.032 | |
| Non-Drinking Outcomes | ||||||||||
| % abstinent from nicotinea | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | N/A | 1.000 | |
| % abstinent from smokingb | 0.0 | 0 | 0 | 0.0 | 0 | 0 | 0.0 | N/A | 1.000 | |
| LSMEAN | SE | 95% CI | LSMEAN | SE | 95% CI | LSMEAN Δ | SE | d | p | |
| Cigarettes per weekb | 64.0 | 7.6 | 48.0 – 80.1 | 47.0 | 7.7 | 30.6 – 63.4 | −17.0 | 10.9 | −0.25 | 0.198 |
| Penn Alcohol Craving | 10.9 | 1.1 | 8.7 – 13.0 | 10.8 | 1.1 | 8.7 – 13.0 | 0.0 | 1.5 | 0.00 | 0.997 |
| Self-report Habit Index | 44.4 | 3.3 | 37.8 – 51.0 | 48.7 | 3.3 | 42.1 – 55.4 | 4.3 | 4.6 | 0.15 | 0.352 |
| Pittsburg Sleep Quality Inventory | 6.0 | 0.4 | 5.1 – 6.9 | 5.3 | 0.4 | 4.4 – 6.2 | −0.6 | 0.6 | −0.18 | 0.557 |
| POMS | 7.3 | 3.9 | −0.6 – 15.2 | 2.9 | 3.9 | −5.0 – 10.8 | −4.5 | 5.5 | −0.15 | 0.325 |
Note. HDD = heavy drinking days, LSMEANS = least squared means, SE = standard error, CI = confidence interval, Δ = varenicline - placebo difference, denom = denominator, d= Cohen’s d (varenicline-placebo), aOR = adjusted odds ratio, POMS = Profile of Mood Scale (POMS) - Total Mood Disturbance score Models were based on a mITT population that included subjects who received at least one dose of medication. No imputation was used for missing data. For continuous outcomes, LSMEANS were estimated from fully adjusted models on untransformed outcomes (for interpretive purposes); corresponding Cohen’s d and p-values were based on the same model but with the appropriately transformed outcome.
% subjects; model for any nicotine outcome included only 21 participants who were nicotine users at baseline and had non-missing data (varenicline n=11, placebo n=10).
% subjects; models for smoking outcomes included only 20 participants who were smokers at baseline and had non-missing data (varenicline n=9, placebo n=11