TABLE 2.

Efficacy analyses of primary and secondary outcomes over a 12-week randomized controlled trial of targeted oral naltrexone for mild to moderate alcohol use disorder in sexual and gender minority men^a

Outcome Measure
	IRR	95% CI	p
Primary binge-drinking outcomes
Number of drinks in past 30 days
Intention-to-treat analysis	0.69	0.52, 0.91	0.01
Sensitivity analysis adjusting for correlates of missingness	0.69	0.54, 0.89	0.004
As-treated analysis	0.79	0.61, 1.03	0.09
Any binge drinking in past week
Intention-to-treat analysis	0.83	0.72, 0.96	0.01
Sensitivity analysis adjusting for correlates of missingness	0.81	0.70, 0.93	0.003
As-treated analysis	0.84	0.71, 0.99	0.04
Number of drinking days in past week
Intention-to-treat analysis	0.98	0.85, 1.13	0.80
Sensitivity analysis adjusting for correlates of missingness	0.97	0.84, 1.14	0.74
As-treated analysis	0.97	0.80, 1.18	0.77
Number of binge-drinking days in past week
Intention-to-treat analysis	0.74	0.56, 0.98	0.03
Sensitivity analysis adjusting for correlates of missingness	0.70	0.53, 0.93	0.01
As-treated analysis	0.67	0.47, 0.96	0.03
Alcohol use biomarker outcomes
Ethyl glucuronide (EtG) positivity (>100 ng/mL)
Intention-to-treat analysis	1.02	0.83, 1.26	0.84
Sensitivity analysis adjusting for correlates of missingness	1.01	0.82, 1.24	0.93
Sensitivity analysis imputing missing urine samples as positive	1.06	0.90, 1.25	0.50
As-treated analysis	0.97	0.76, 1.25	0.82
Phosphatidylethanol (PEth) positivity (>20 ng/mL)
Intention-to-treat analysis	0.92	0.79, 1.08	0.33
Sensitivity analysis adjusting for correlates of missingness	0.92	0.79, 1.08	0.31
Sensitivity analysis imputing missing dried blood spot samples as positive	0.92	0.79, 1.07	0.30
As-treated analysis	0.84	0.69, 1.03	0.10
	Coefficient	95% CI	p
Phosphatidylethanol (PEth) concentration
Intention-to-treat analysis	−37.37	−77.94, 3.21	0.07
Sensitivity analysis adjusting for correlates of missingness	−36.16	−76.96, 4.65	0.08
As-treated analysis	−55.47	−110.75, −0.20	0.04
Secondary outcomes
Alcohol craving visual analogue scale rating	−9.25	−17.20, −1.31	0.02
Alcohol Use Disorders Identification Test score	−0.49	−2.40, 1.42	0.62
Severity of Alcohol Dependence Scale score	−0.15	−0.76, 0.45	0.62
Center for Epidemiologic Studies Depression Scale score	−1.12	−3.46, 1.23	0.35
	IRR	95% CI	p
Sexual behavior outcomes
Number of male partners	1.21	0.84, 1.75	0.30
Number of nonprimary male partners	1.48	0.96, 2.30	0.08
Number of male partners whom participant drank alcohol with	0.94	0.64, 1.38	0.76
Anal intercourse with HIV serodiscordant partners	1.26	0.72, 2.20	0.42
Condomless anal intercourse with HIV serodiscordant partners	1.21	0.67, 2.19	0.52
Receptive anal intercourse with HIV serodiscordant partners	1.22	0.59, 2.52	0.59
Receptive condomless anal intercourse with HIV serodiscordant partners	1.55	0.73, 3.28	0.25
Insertive anal intercourse with HIV serodiscordant partners	1.42	0.62, 3.26	0.40
Insertive condomless anal intercourse with HIV serodiscordant partners	1.88	0.66, 5.39	0.24

^aIRR=incidence rate ratio.