Table 4.

Adverse Events related or possibly related to the study medication

	Naltrexone (n=96)	Placebo (n=98)	p value*
# Participant affected	49 (51%)	40 (40.8%)	.19
Severe Adverse Events	0	0	-
Other Adverse Events
Nausea	22 (22.9%)	14 (14.3%)	.12
Increased Appetite	14 (14.6%)	11 (11.2%)	.49
Itchiness	6 (6.3%)	9 (9.2%)	.44
Fatigue	8 (8.3%)	5 (5.1%)	.37
Dizziness	8 (8.3%)	4 (4.1%)	.22
Decreased Appetite	5 (5.2%)	6 (6.1%)	.78
Sleepiness	7 (7.3%)	4 (4.1%)	.33
Abdominal Pain	7 (7.3%)	3 (3.1%)	.21
Diarrhea	8 (8.3%)	1 (1.0%)	.02
Vomiting	7 (8.3%)	2 (2.0%)	.10
Headache	1 (1.0%)	6 (6.1%)	.12
Nervousness/Anxiety	2 (2.1%)	4 (4.1%)	.68
Insomnia	2 (2.1%)	2 (2.0%)	1
Abnormal liver lab value	2 (2.1%)	1 (1.0%)	.62
Depression	2 (2.1%)	0 (0.0%)	.24
Constipation	1 (1.0%)	0 (0.0%)	.49
Upset stomach	0 (0.0%)	1 (1.0%)	1

^*p value based on chi-square test