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

NCT03169816 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 7501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lorcaserin

EXPERIMENTAL

10 mg capsule taken twice daily of lorcaserin

Drug: Lorcaserin

Placebo

PLACEBO COMPARATOR

a placebo comparator capsule taken twice daily

Drug: Placebo

Interventions

Lorcaserin DRUG

Lorcaserin 10mg, twice daily

Lorcaserin

Placebo DRUG

Matched placebo for lorcaserin condition dosed twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Individuals between the ages of 18-60
• \. Meets DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids
• \. Seeking treatment for opioid use disorder
• \. Capable of giving informed consent and complying with study procedures
• \. Not underweight; defined as BMI≥18.5

You may not qualify if:

• Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
• A recent history of binge-use of alcohol or sedative-hypnotics (using large amounts in a short time to severe intoxication or blackouts).
• Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men.
• Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension (blood pressure \> 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease.
• Legally mandated to participate in a substance use disorder treatment program.
• Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide
• Currently meets DSM-5 diagnosis for an eating disorder with low body weight (BMI \<20)
• 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.
• Elevated liver function tests (AST and ALT \> 3 times the upper limit of normal) or impaired renal function (GFR\<60 ml/min)
• Known history of allergy, intolerance, or hypersensitivity to lorcaserin, naltrexone or any other study medications
• 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Substance Treatment and Research Service (STARS), Columbia University

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Frances R Levin, MD
• Organization: New York State Psychiatric Institute

frl2@columbia.edu

6467746137

Study Officials

• Frances R Levin, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: May 25, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)