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

Opioid-use Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 measures will be the proportion of patients successfully inducted onto XR-naltrexone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03169816
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 25, 2017
Completion date August 30, 2019
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