ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to
assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All
subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).
Planned treatment duration was up to 3 years. Alkermes terminated the study for business
purposes in December 2006. The median duration of treatment among all subjects in this
extension study was 43 weeks.
Naltrexone & SSRI in Alcoholics With Depression/PTSD
The purpose of this study is to evaluate the efficacy of naltrexone in combination with an
SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.
We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease
in alcohol consumption than that seen with treatment with SSRI alone, or with a combination
of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be
effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
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