NCT03169816

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Lorcaserin	Lorcaserin 10mg, twice daily
DRUG	Placebo	Matched placebo for lorcaserin condition dosed twice daily

Timeline

• Start date: 2017-05-25
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2017-05-30
• Last updated: 2020-10-05
• Results posted: 2020-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study