Lorcaserin in the Treatment of Cocaine Use Disorder

Overview

The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.

Full Title of Study: “Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 1, 2019

Detailed Description

This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.

Interventions

  • Drug: Lorcaserin
    • Lorcaserin Capsule
  • Drug: Placebo Oral Capsule
    • sugar pill to mimic lorcaserin 10mg capsule

Arms, Groups and Cohorts

  • Active Comparator: Lorcaserin
    • 10 mg capsule by mouth, twice a day, for 13 weeks
  • Placebo Comparator: Placebo Oral Capsule
    • 10 mg placebo capsule, twice a day, for 13 weeks

Clinical Trial Outcome Measures

Primary Measures

  • The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the “Pre-qualified for Primary Efficacy Endpoint” (PPEE) Population
    • Time Frame: Treatment weeks 11 – 13
    • Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period.

Secondary Measures

  • The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence
    • Time Frame: Treatment weeks 11-13

Participating in This Clinical Trial

Inclusion Criteria

  • Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5 – Is seeking treatment for cocaine use disorder – Is able to understand and provide written informed consent – Has used cocaine on at least 1 day in the last 30 days prior to screening – Has completed all psychological assessments and procedures during the screening period – If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control – Has a total body weight greater than 110 pounds and body mass index greater than 20 Exclusion Criteria:

  • Contact site for more information

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shwe Gyaw, MD, Study Chair, National Institute on Drug Abuse (NIDA)

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