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

NCT ID: NCT03169816

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2019-08-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lorcaserin

10 mg capsule taken twice daily of lorcaserin

Group Type: EXPERIMENTAL

Lorcaserin

Intervention Type: DRUG

Lorcaserin 10mg, twice daily

Placebo

a placebo comparator capsule taken twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo for lorcaserin condition dosed twice daily

Interventions

Lorcaserin

Lorcaserin 10mg, twice daily

Intervention Type: DRUG

Placebo

Matched placebo for lorcaserin condition dosed twice daily

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Frances R Levin

Director of Substance Use Disorder

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frances R Levin, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

Substance Treatment and Research Service (STARS), Columbia University

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

7501

Identifier Type: -

Identifier Source: org_study_id