buprenorphine, over 18 (ASI) All were levomethadyl mos) monthly given free to survival acetate/LAAM, pts. Manualized Durability of analysis methadone, other individual effects: Results (retention) prescription drug retention, reflect a opioids, counseling opioid select antipsychotics, monthly craving subpopulation anticonvulsants, (VAS of antidepressants Permitted predominantly and anxiolytics. co-meds: and abstinent, AEDs if Predominantly EQ-5D probably dosing was young (29.5 yo), health more highly stable and male (89%), white function, motivated pts. short-acting (100%), addicted CGII PRN Pts were not to heroin for about insomnia Responders tracked after 10 years, and had medications were dropout from high rates of HIV defined a tx. (40%) and HCV priori as (88%) infection. External CGII of 1 validity to VA: (very much) Possible or 2 (much) improved Safety: TEAEs, VS, urine/blood tests inc LFTs, injection sites, ECG Table Results of Major Efficacy Trial, Weeks (Krupitsky, 2011) Relative Effect ER-NTX PBO Outcome (95% Measures (N=126) (N=124) CI) P-value Primary Outcome Measures Proportion of 90.0 35.0 Diff 0.0002 weeks of 55.0 confirmed abstinence, % (95% CI) Pts with total 35.7 22.6 RR 0.0224 confirmed 1.58 abstinence, % (95% CI) Diff 13.1
survival analysis (retention) buprenorphine, levomethadyl acetate/LAAM, methadone, other prescription opioids, antipsychotics, anticonvulsants, antidepressants and anxiolytics. Predominantly young (29.5 yo), male (89%), white (100%), addicted to heroin for about 10 years, and had high rates of HIV (40%) and HCV (88%) infection. over 18 mos) Manualized individual drug counseling monthly Permitted co-meds: AEDs if dosing was stable and short-acting PRN insomnia medications (ASI) monthly Durability of effects: retention, opioid craving (VAS and EQ-5D health function, CGII Responders were defined a priori as CGII of 1 (very much) or 2 (much) improved Safety: TEAEs, VS, urine/blood tests inc LFTs, injection sites, ECG All were given free to pts. Results reflect a select subpopulation of predominantly abstinent, probably more highly motivated pts. Pts were not tracked after dropout from tx. External validity to VA: Possible Table Results of Major Efficacy Trial, Weeks (Krupitsky, 2011) Outcome Measures ER-NTX (N=126) PBO (N=124) Relative Effect (95% CI) P-value Primary Outcome Measures Proportion of weeks of confirmed abstinence, % (95% CI) 90.0 35.0 Diff 55.0 0.0002 Pts with total confirmed abstinence, % (95% CI) 35.7 22.6 RR 1.58 Diff 13.1 0.0224