Precision of Results: The 95% CI for the treatment difference for one of two primary outcome measures (percentage of weeks of confirmed abstinence) was wide but excluded the possibility that ER-NTX was not better than PBO. The 95% CI for the relative risk of benefit for the other primary outcome measure (patients with total confirmed abstinence) was narrow but the lower limit (1.06) approached 1.00, suggesting a possibility that ER-NTX was not superior. External Validity to VA: The study results were applicable to a selected subgroup of Russian opioid addicts and there were many exclusions to study entry. Nonetheless, there is no reason to exclude the U.S. Veteran opioid addict population from a therapeutic of ER-NTX. Table Summary of Naltrexone ER Injection Studies in Opioid Dependence Reference Design, Findings Study Population Krupitsky 24-wk PC ER-NTX was (2011) RCT superior to PBO in terms of patients Median receiving proportion ER-NTX 380 of weeks mg once of every 4 confirmed weeks in opioid combination with during psychosocial weeks support 24 (primary endpoint): 90% vs. 35%; 55% of patients who achieved total confirmed 36% vs. 23%; RR 1.58 NNT 8 (95% CI 5–55) Reduction in opioid
Precision of Results: The 95% CI for the treatment difference for one of two primary outcome measures (percentage of weeks of confirmed abstinence) was wide but excluded the possibility that ER-NTX was not better than PBO. The 95% CI for the relative risk of benefit for the other primary outcome measure (patients with total confirmed abstinence) was narrow but the lower limit (1.06) approached 1.00, suggesting a possibility that ER-NTX was not superior. External Validity to VA: The study results were applicable to a selected subgroup of Russian opioid addicts and there were many exclusions to study entry. Nonetheless, there is no reason to exclude the U.S. Veteran opioid addict population from a therapeutic of ER-NTX. Table Summary of Naltrexone ER Injection Studies in Opioid Dependence Reference Design, Study Population Findings Krupitsky (2011) 24-wk PC RCT patients receiving ER-NTX 380 mg once every 4 weeks in combination with psychosocial support ER-NTX was superior to PBO in terms of Median proportion of weeks of confirmed opioid during weeks (primary endpoint): 90% vs. 35%; 55% of patients who achieved total confirmed 36% vs. 23%; RR 1.58 NNT 8 (95% CI 5–55) Reduction in opioid 24