Lorcaserin in the Treatment of Cocaine Use Disorder

Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder

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

Study Overview

• Status: Completed
• Conditions: Cocaine-Related Disorders
• Intervention / Treatment: Drug: Lorcaserin; Drug: Placebo Oral Capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92307
      • Pacific Treatment and Research Center
    • Los Angeles, California, United States, 90016
      • Matrix Institute on Addictions
    • Newport Beach, California, United States, 92660-2452
      • Pharmacology Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University
  • Florida
    • Lakeland, Florida, United States, 33805
      • Meridien Research
    • North Miami, Florida, United States, 33161
      • Behavioral Clinical Research, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02118-2391
      • Boston University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research Institute
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research Inc.
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97214
      • CODA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lorcaserin; 10 mg capsule by mouth, twice a day, for 13 weeks	Drug: Lorcaserin; Lorcaserin Capsule; Other Names: Belviq; lorcaserin hydrochloride
PLACEBO_COMPARATOR: Placebo Oral Capsule; 10 mg placebo capsule, twice a day, for 13 weeks	Drug: Placebo Oral Capsule; sugar pill to mimic lorcaserin 10mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Treatment weeks 11 - 13

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Treatment weeks 11-13

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Study Chair: Shwe Gyaw, MD, National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 19, 2017
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (ESTIMATE): January 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cocaine Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Cocaine-Related Disorders
• Other Study ID Numbers: NIDA/VACSP #1033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No