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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 : Completed
First Posted : May 30, 2017
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE May 25, 2017
First Posted Date  ICMJE May 30, 2017
Results First Submitted Date  ICMJE August 25, 2020
Results First Posted Date  ICMJE October 5, 2020
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE May 25, 2017
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
Proportion of Patients Successfully Inducted to Receive Naltrexone Injection [ Time Frame: Study week 1 ]
proportion of individuals who were successfully inducted and received the first XR-naltrexone injection
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
Proportion of patients successfully retained to receive 2nd naltrexone injection [ Time Frame: Study week 5 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder
Official Title  ICMJE Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE
  • Drug: Lorcaserin
    Lorcaserin 10mg, twice daily
  • Drug: Placebo
    Matched placebo for lorcaserin condition dosed twice daily
Study Arms  ICMJE
  • Experimental: Lorcaserin
    10 mg capsule taken twice daily of lorcaserin
    Intervention: Drug: Lorcaserin
  • Placebo Comparator: Placebo
    a placebo comparator capsule taken twice daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03169816
Other Study ID Numbers  ICMJE 7501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frances R Levin, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frances R Levin, MD NYSPI
PRS Account New York State Psychiatric Institute
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP