Table 2.

Cocaine Use during Evaluation Period (Days 25–54) and Follow-Up

	PLB	BUP4	BUP4 vs. PLB	BUP16	BUP16 vs. PLB
PRIMARY OUTCOME
Number of days of cocaine use during the evaluation period
N	102	100		100
Mean (SD)	8.2 (6.84)	7.8 (7.23)		7.9 (7.72)
P-value (one-sided)	-	0.262		0.185
Rank-biserial correlation		−0.09		−0.08
SECONDARY OUTCOMES
Longitudinal analysis of UDS-based abstinence during the evaluation period
N	100	95		97
Proportion UDS abstinent	45.8%	50.4%		50.9%
Odds Ratio (95% one-sided CI)			1.09 (0.75, ∞)		1.71 (1.19, ∞)
P-value (one-sided)			0.105		0.022
UDS 100% abstinent during evaluation period
N	100	95		97
Proportion 100% abstinent	16.0%	17.9%		18.6%
Odds Ratio (95% one-sided CI)			1.14 (0.61, ∞)		1.19 (0.64, ∞)
P-value (one-sided)			0.362		0.318
UDS ≥75% abstinent during evaluation period
N	100	95		97
Proportion ≥75% abstinent	28.0%	33.7%		41.2%
Odds Ratio (95% one-sided CI)			1.31 (0.78, ∞)		1.80 (1.10, ∞)
P-value (one-sided)			0.410		0.008
UDS-based abstinence at follow-up visits
One month follow-up
N	97	91		93
Proportion abstinent	48.5%	49.5%		45.2%
Odds Ratio (95% one-sided CI)			1.04 (0.64, ∞)		0.88 (0.54, ∞)
P-value (one-sided)			0.446		0.325
Three month follow-up
N	93	86		88
Proportion abstinent	50.5%	52.3%		54.6%
Odds Ratio (95% one-sided CI)			1.07 (0.66, ∞)		1.17 (0.72, ∞)
P-value (one-sided)			0.406		0.295
Higher use cocaine subsample analysis of the number of days of cocaine use from ASI
N	24	12		14
Mean (SD) change (baseline - week 8)	7.7 (8.1)	18.8 (7.7)		13.2 (10.0)
Proportion of variance due to BUP			45.9%		9.7%
P-value (one-sided)			<0.001		0.035