Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder

  • STATUS
    Not Recruiting
  • participants needed
    60
  • sponsor
    New York State Psychiatric Institute
Updated on 19 September 2021

Summary

This study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into our program of outpatient detoxification and naltrexone induction followed by a relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or placebo (N = 20) with weekly therapy.

Description

The study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into our program of outpatient detoxification and naltrexone induction followed by a relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or placebo (N = 20) with weekly therapy. Lorcaserin or placebo 10 mg bid will be started on Day 1 of the study to address acute withdrawal, then maintained over the next 5 weeks, and stopped after the second XR-naltrexone is administered. Patients will be seen twice weekly for monitoring and offered two injections of naltrexone; at the end of oral naltrexone induction (end of week 1) and four weeks later (week 5). The primary outcome measure will be the proportion of patients successfully retained to receive the second naltrexone injection. Patients retained to this point tend to stay on treatment and do well long term, hence this is the most clinically relevant outcome to evaluate treatment initiation.

Details
Condition Opioid Use Disorder
Treatment Placebo, Lorcaserin
Clinical Study IdentifierNCT03169816
SponsorNew York State Psychiatric Institute
Last Modified on19 September 2021

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