NNT 8 (5–55) Secondary Outcome Measures Proportion of 99.2 60.4 Diff 0.0004 self-reported 38.7 opioid-free days, % Craving: mean 0.7 Diff <0.0001 –10.1 change in VAS to to score from BL 4.4) to 6.4) Number of days >168 (CI 96 RR 0.0042 of retention not 0.61 calculable) Pts with positive 0.8 13.7 RR <0.0001 naloxone 17.3 challenge test, % Other Outcomes Pts who 53.2 37.9 RR 0.0171 completed DB 1.40 tx period, % Risk for HIV: Diff 0.0212 –0.187 –0.130 mean change in to (–0.173 behavior scores to (–0.113 from BL to EQ-5D: mean 14.1 2.7 Diff 0.0005 change in VAS 11.4 self-ratings from BL Rated much or 85.9 57.5 1.49 0.0002 very much (45.7 improved on CGI, % Safety SAEs, % of pts 2 3 Diff NSD –1 % of pts 2 2 Diff 0 — % of pts 26 10 Diff 16 0.001
NNT 8 (5–55) Secondary Outcome Measures Proportion of self-reported opioid-free days, % 99.2 60.4 Diff 38.7 0.0004 Craving: mean change in VAS score from BL –10.1 to 0.7 to 4.4) Diff to 6.4) <0.0001 Number of days of retention >168 (CI not calculable) 96 RR 0.61 0.0042 Pts with positive naloxone challenge test, % 0.8 13.7 RR 17.3 <0.0001 Other Outcomes Pts who completed DB tx period, % 53.2 37.9 RR 1.40 0.0171 Risk for HIV: mean change in behavior scores from BL –0.187 to –0.130 (–0.173 to Diff (–0.113 to 0.0212 EQ-5D: mean change in VAS self-ratings from BL 14.1 2.7 Diff 11.4 0.0005 Rated much or very much improved on CGI, % 85.9 57.5 (45.7 1.49 0.0002 Safety SAEs, % of pts 2 3 Diff –1 NSD % of pts 2 2 Diff 0 — % of pts 26 10 Diff 16 0.001
Naltrexone_ER_Susp_Inj_Monograph_Addendum_2014.docx