Table 1.
Adjusted Mean Percent Heavy Drinking Days (Weeks 2–12) by Treatment Group and Moderator
| Moderator | Subgroup | Placebo | Varenicline | LSMEANs | Moderator* Treatment Interaction p-value | Patterns in Treatment Effects: Consistency of Other Outcomes with PHDD | Moderator* Treatment Interaction p-values for Other Outcomesa | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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| N | LSMean | 95% CI | N | LSMean | 95% CI | Difference | SE | p | |||||
|
Baseline Characteristics
| |||||||||||||
| Treatment Drinking Goal | Other | 73 | 62.8 | 55.3 – 70.3 | 69 | 44.8 | 37.2 – 52.5 | −18.0 | 5.3 | 0.00 | 0.01 | Inconsistent | All p>.05 |
| Total Abstinence | 28 | 28.2 | 16.5 – 39.9 | 27 | 36.9 | 24.9 – 48.9 | 8.7 | 8.3 | 0.29 | ||||
|
| |||||||||||||
| Years Drinking Regularly | ≤28 | 54 | 47.9 | 39.1 – 56.6 | 44 | 49.3 | 39.9 – 58.8 | 1.5 | 6.2 | 0.82 | 0.01 | Consistent | All p<.05, except DPDD (p=.10) |
| >28 | 47 | 47.5 | 38.0 – 57.1 | 52 | 27.1 | 18.0 – 36.2 | −20.4 | 6.2 | 0.00 | ||||
|
| |||||||||||||
| Age | ≤45 | 50 | 47.7 | 38.6 – 56.8 | 38 | 48.5 | 38.1 – 59.0 | 0.8 | 6.7 | 0.90 | 0.04 | Consistent | All p<.05, except PVHDD (p=.37), DPDD (p=.36) |
| >45 | 51 | 48.1 | 38.8 – 57.5 | 58 | 30.4 | 21.6 – 39.2 | −17.8 | 6.0 | 0.00 | ||||
|
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| Alcohol Consequences (ImBIBe) Scoreb | ≤ 22 | 72 | 53.7 | 45.4 – 62.0 | 60 | 38.3 | 29.6 – 47.0 | −15.4 | 5.5 | 0.01 | 0.07 | Consistent | All p>.05 |
| > 22 | 29 | 37.0 | 25.2 – 48.7 | 35 | 38.8 | 27.6 – 50.0 | 1.8 | 7.8 | 0.81 | ||||
|
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| Drinks per Days (7 days pre-randomization) | ≤7/9 women/men | 43 | 41.6 | 31.5 – 51.6 | 41 | 24.3 | 14.0 – 34.6 | −17.3 | 6.7 | 0.01 | 0.15 | Consistent, except PVHDD & PACS | All p>.05 |
| >7/9 women/men | 58 | 52.1 | 43.7 – 60.5 | 55 | 47.5 | 38.6 – 56.4 | −4.6 | 5.8 | 0.43 | ||||
|
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| Alcohol Craving (PACS) Score | ≤20 | 69 | 45.4 | 36.2 – 54.6 | 63 | 30.9 | 22.1 – 39.7 | −14.5 | 5.6 | 0.01 | 0.16 | Consistent, except PACS | All p>.05, except DPDD (p=.05) |
| >20 | 32 | 53.9 | 41.0 – 66.9 | 33 | 52.9 | 39.7 – 66.2 | −1.0 | 7.8 | 0.90 | ||||
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| Marijuana Use | No | 89 | 47.0 | 39.7 – 54.3 | 82 | 38.8 | 31.2 – 46.4 | −8.2 | 4.9 | 0.10 | 0.17 | Consistent | All p<.05, except DPD (p=.05), PACS (p=.20) |
| Yes | 12 | 58.4 | 40.3 – 76.5 | 14 | 32.4 | 15.7 – 49.2 | −26.0 | 12.2 | 0.03 | ||||
|
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| Pre-Randomization Reducer (DPD) | No | 31 | 58.7 | 46.5 – 70.8 | 28 | 38.9 | 26.7 – 51.1 | −19.8 | 8.2 | 0.02 | 0.17 | Consistent, except PACS | All p>.05 |
| Yes | 70 | 44.3 | 36.4 – 52.2 | 68 | 38.0 | 29.9 – 46.0 | −6.3 | 5.4 | 0.24 | ||||
|
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| Parental Problem Drinking | No | 51 | 48.6 | 39.2 – 58.1 | 44 | 32.7 | 22.8 – 42.6 | −16.0 | 6.5 | 0.01 | 0.24 | Consistent | All p>.05 |
| Yes | 50 | 47.9 | 38.7 – 57.0 | 52 | 42.5 | 33.2 – 51.8 | −5.4 | 6.4 | 0.40 | ||||
|
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| Gender | Female | 32 | 47.8 | 36.6 – 59.1 | 25 | 30.3 | 17.5 – 43.0 | −17.6 | 8.4 | 0.04 | 0.33 | Inconsistent | All p>.05 |
| Male | 69 | 48.6 | 40.5 – 56.7 | 71 | 40.5 | 32.5 – 48.5 | −8.1 | 5.4 | 0.13 | ||||
|
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| Withdrawal (MINI) | No | 59 | 43.5 | 34.4 – 52.5 | 61 | 36.9 | 28.4 – 45.5 | −6.5 | 5.8 | 0.26 | 0.33 | Inconsistent | All p>.05 |
| Yes | 42 | 54.2 | 44.3 – 64.1 | 35 | 38.7 | 27.8 – 49.7 | −15.5 | 7.2 | 0.03 | ||||
|
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| Drinks per Day (28 days pre-screening) | ≤7/9 women/men | 37 | 43.4 | 32.4 – 54.5 | 28 | 26.9 | 14.2 – 39.6 | −16.5 | 7.7 | 0.03 | 0.37 | Inconsistent | All p>.05 |
| >7/9 women/men | 64 | 50.5 | 42.2 – 58.8 | 68 | 42.3 | 34.1 – 50.6 | −8.2 | 5.5 | 0.14 | ||||
|
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| GGT | Non-Elevated | 66 | 49.9 | 41.5 – 58.3 | 62 | 36.8 | 28.1 – 45.5 | −13.1 | 5.7 | 0.02 | 0.43 | Consistent | All p>.05 |
| Elevated | 35 | 45.6 | 34.8 – 56.5 | 34 | 40.1 | 29.0 – 51.1 | −5.6 | 7.6 | 0.47 | ||||
|
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| # Alcohol Dependence Criteria | 3–5 | 79 | 48.4 | 40.4 – 56.3 | 73 | 38.6 | 30.7 – 46.4 | −9.8 | 5.2 | 0.06 | 0.80 | Consistent | All p>.05 |
| 6–7 | 22 | 48.1 | 34.1 – 62.0 | 23 | 35.5 | 21.8 – 49.2 | −12.6 | 9.5 | 0.19 | ||||
|
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|
Variables Observed During the Treatment Period
| |||||||||||||
| Change in Cigarettes per Day (among Smokers)c | No change or increase | 22 | 51.6 | 38.3 – 65.0 | 9 | 68.3 | 49.5 – 87.1 | 16.7 | 11.4 | 0.15 | 0.02 | Consistent | All p<.01, except PACS (p=.69) |
| Reduction | 16 | 55.4 | 41.3 – 69.6 | 27 | 36.1 | 24.2 – 48.0 | −19.3 | 9.2 | 0.04 | ||||
|
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| Varenicline-Consistent Adverse Event (AE) | No AE | 11 | 65.1 | 46.1 – 84.1 | 9 | 35.5 | 14.8 – 56.1 | −29.6 | 14.1 | 0.04 | 0.06 | Consistent, except PACS | All p>.05 |
| Other AE | 60 | 43.6 | 35.2 – 52.0 | 32 | 45.0 | 33.3 – 56.7 | 1.4 | 7.0 | 0.84 | ||||
| Varenicline-Consistent AE | 30 | 52.5 | 40.9 – 64.1 | 55 | 34.5 | 25.8 – 43.2 | −18.0 | 7.1 | 0.01 | ||||
|
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| Compliance | ≤ 305 pills taken | 28 | 53.8 | 41.3 – 66.4 | 20 | 38.7 | 23.6 – 53.7 | −15.2 | 9.5 | 0.11 | 0.55 | Inconsistent | All p>.05 |
| >305 pills taken | 73 | 46.5 | 38.6 – 54.4 | 76 | 37.8 | 30.2 – 45.3 | −8.7 | 5.2 | 0.09 | ||||
Abbreviations: LSMEANS=least squares means; CI=confidence interval; PHDD=percent heavy drinking days; PVHDD=percent very heavy drinking days; PACS=Penn Alcohol Craving Scale; DPDD=drinks per drinking day; DPD=drinks per day; rand=randomization; GGT=gamma-glutamyl transpeptidase
Note: moderators with a statistically significant treatment interaction are shaded in gray.
a
Other outcomes include percent very heavy drinking days, drinks per day, drinks per drinking day, and the Penn Alcohol Craving Scale
b
ImBIBe missing 1 subject in varenicline group
c
Change in Cigarettes per Day (among Smokers) missing 3 placebo subjects and 1 varenicline subject