Last updated on February 2018

Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

Brief description of study

To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.

Detailed Study Description

1.2.1 Primary and Secondary Outcome Measures

Primary outcomes are:

  1. Opiate positive urine tests; 2) HIV injecting risk.

Secondary outcomes are:

  1. Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.

Hypotheses are that:

  1. Primary outcomes will significantly favor the 48-week Vivitrol condition;
  2. Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.

Clinical Study Identifier: NCT01882361

Contact Investigators or Research Sites near you

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Tatiana Klimenko, MD, PhD

Federal Medical Research Center for Psychiatry and Narcology (FMRC)
Moscow, Russian Federation
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