CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Lorcaserin +1 moredrug
Likely dose
Lorcaserin 10 mg orally twice dailyAI-extracted
Key inclusion· 4
  • ✓Age 18-60 years
  • ✓Current DSM-5 opioid use disorder present for at least 6 months, confirmed by positive urine drug screen for opioids
  • ✓Actively seeking treatment for opioid use disorder
  • ✓BMI ≥18.5 (not underweight)
Key exclusion· 10
  • ✕Lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
  • ✕Current unstable psychiatric disorder or concurrent psychotropic medication use
  • ✕Severe substance use disorder other than opioid or nicotine, or physiological dependence on alcohol or sedative-hypnotics
  • ✕Recent binge use of alcohol or sedative-hypnotics to severe intoxication or blackouts

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03169816
NCT03169816Phase 3Completed
CompareCT.gov

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

New York State Psychiatric Institute·interventional·Posted May 30, 2017·Updated Oct 5, 2020

In Brief

A Phase 3 clinical trial evaluating Lorcaserin and Placebo for Opioid-use Disorder. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-use Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartMay 25, 2017
Primary CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.1 years ago

Interventions

Lorcaserindrug

Lorcaserin 10mg, twice daily

Placebodrug

Matched placebo for lorcaserin condition dosed twice daily