Lorcaserin in the Treatment of Cocaine Use Disorder

• ClinicalTrials.gov Identifier: NCT03007394
• Recruitment Status: Completed
• First Posted: January 2, 2017
• Results First Posted: June 19, 2020
• Last Update Posted: August 5, 2020
• Sponsor: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): National Institute on Drug Abuse (NIDA)

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cocaine-Related Disorders	Drug: Lorcaserin; Drug: Placebo Oral Capsule	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
• Actual Study Start Date: December 19, 2017
• Actual Primary Completion Date: December 1, 2019
• Actual Study Completion Date: December 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Pacific Treatment and Research Center

La Jolla, California, United States, 92307

Matrix Institute on Addictions

Los Angeles, California, United States, 90016

Pharmacology Research Institute

Newport Beach, California, United States, 92660-2452

United States, District of Columbia

George Washington University

Washington, District of Columbia, United States, 20052

United States, Florida

Meridien Research

Lakeland, Florida, United States, 33805

Behavioral Clinical Research, Inc.

North Miami, Florida, United States, 33161

United States, Massachusetts

Boston University School of Medicine

Boston, Massachusetts, United States, 02118-2391

United States, Nevada

Altea Research Institute

Las Vegas, Nevada, United States, 89102

United States, New Jersey

Hassman Research Institute

Berlin, New Jersey, United States, 08009

United States, Ohio

Neuro-Behavioral Clinical Research Inc.

Canton, Ohio, United States, 44718

University of Cincinnati

Cincinnati, Ohio, United States, 45229

United States, Oregon

CODA, Inc.

Portland, Oregon, United States, 97214

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

  Study Documents (Full-Text)

Documents provided by National Institute on Drug Abuse (NIDA):

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2017

More Information

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT03007394
• Other Study ID Numbers: NIDA/VACSP #1033
• First Posted: January 2, 2017
• Results First Posted: June 19, 2020
• Last Update Posted: August 5, 2020
• Last Verified: February 2020

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

Keywords provided by National Institute on Drug Abuse (NIDA):

Cocaine Use Disorder

Additional relevant MeSH terms:

Disease; Cocaine-Related Disorders; Pathologic Processes; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders