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

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ClinicalTrials.gov Identifier: NCT03169816
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Lorcaserin Drug: Placebo Phase 2 Phase 3

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 measure will be the proportion of patients successfully retained to receive the second naltrexone injection. Patients retained to this point tend to stay on treatment and do well long term, hence this is the most clinically relevant outcome to evaluate treatment initiation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of patients successfully retained to receive 2nd naltrexone injection [ Time Frame: Study week 5 ]
    proportion of individuals who receive the 2nd Vivitrol injection at week 5 of the trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169816


Contacts
Contact: Amy Mahony, LMHC 646-774-8183 Amy.mahony@nyspi.columbia.edu

Locations
United States, New York
Substance Treatment and Research Service (STARS), Columbia University Recruiting
New York, New York, United States, 10019
Contact: Elizabeth Martinez    212-923-3031    MARTINE@NYSPI.COLUMBIA.EDU   
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Frances R Levin, MD NYSPI

Responsible Party: Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03169816     History of Changes
Other Study ID Numbers: 7501
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Pathologic Processes
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents