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THURSDAY, April 28 (HealthDay News) -- A once-monthly injection of extended-release naltrexone (XR-NTX) appears to be effective and safe for the treatment of opioid dependence after detoxification, according to a study published online April 28 in The Lancet.
In a double-blind, placebo-controlled, 24-week study, Evgeny Krupitsky, M.D., of the St. Petersburg State Pavlov Medical University in Russia, and colleagues randomized 250 patients with opioid dependence after detoxification to receive either 380 mg XR-NTX or placebo to assess the efficacy, safety, and patient-reported outcomes associated with XR-NTX. Patients also received 12 biweekly counseling sessions.
The investigators found that the median proportion of weeks of confirmed abstinence was 90 percent among those who received XR-NTX and 35 percent in those who received placebo. The investigators also found that patients who received XR-NTX self-reported a median of 99.2 percent opioid-free days as compared with 60.4 percent for those who received placebo. Median retention was over 168 days in the XR-NTX group but just 96 days in the placebo group. Naloxone challenge confirmed relapse to physiological opioid dependence in 17 patients in the placebo group but only one in the XR-NTX group. The drug was well tolerated, with two patients in each group discontinuing treatment due to adverse events.
"XR-NTX represents a new treatment option that is distinct from opioid agonist maintenance treatment. XR-NTX in conjunction with psychosocial treatment might improve acceptance of opioid dependence pharmacotherapy and provide a useful treatment option for many patients," the authors write.
Several authors disclosed financial relationships with Alkermes, which manufactures XR-NTX and funded the study, as well as other pharmaceutical companies.
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