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

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 Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Drug: Lorcaserin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Substance Treatment and Research Service (STARS), Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Individuals between the ages of 18-60

  2. Meets DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids

  3. Seeking treatment for opioid use disorder

  4. Capable of giving informed consent and complying with study procedures

  5. Not underweight; defined as BMI≥18.5

Exclusion Criteria:

1. Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
2. Current DSM-5 criteria for any other psychiatric disorder that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require pharmacotherapy or psychotherapy during the study period. Concurrent treatment with other psychotropic medication is exclusionary.
3. Individuals who meet DSM-5 criteria for any substance use disorders - severe, other than opioid and nicotine use disorder. Physiological dependence on alcohol or sedative-hypnotics is exclusionary.
4. A recent history of binge-use of alcohol or sedative-hypnotics (using large amounts in a short time to severe intoxication or blackouts).
5. Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men.
6. Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease.
7. Legally mandated to participate in a substance use disorder treatment program.
8. Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide
9. Currently meets DSM-5 diagnosis for an eating disorder with low body weight (BMI <20)
10. History of accidental opioid overdose in the last three years or any other significant history of overdose following detoxification within past 10 years defined as an episode of opioid-induced unconsciousness, whether or not medical treatment was sought or received.
11. Elevated liver function tests (AST and ALT > 3 times the upper limit of normal) or impaired renal function (GFR<60 ml/min)
12. Known history of allergy, intolerance, or hypersensitivity to lorcaserin, naltrexone or any other study medications
13. Concurrent use of migraine medications containing ergotamine (Cafergot, Ergomar) or dihydroergotamine (Migranal), 5HT2B receptor agonists like cabergoline, or medications metabolized by CYP2D6 (thioridazine, tamoxifen, metoprolol, aripiprazole, codeine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lorcaserin; 10 mg capsule taken twice daily of lorcaserin	Drug: Lorcaserin; Lorcaserin 10mg, twice daily
PLACEBO_COMPARATOR: Placebo; a placebo comparator capsule taken twice daily	Drug: Placebo; Matched placebo for lorcaserin condition dosed twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Successfully Inducted to Receive Naltrexone Injection	proportion of individuals who were successfully inducted and received the first XR-naltrexone injection	Study week 1

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: Frances R Levin, MD, NYSPI

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2017
• Primary Completion (ACTUAL): August 30, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 7501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No