Lorcaserin in the Treatment of Cocaine Use Disorder

Phase 2

Completed

• Conditions: Cocaine-Related Disorders
• Interventions: Drug: Lorcaserin; Drug: Placebo Oral Capsule

• Registration Number: NCT03007394
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Study Start: 2017-12-19
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-02
• Results First Submitted: 2020-06-02
• Results First Submitted QC: 2020-06-02
• Results First Posted: 2020-06-19
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lorcaserin	Lorcaserin	10 mg capsule by mouth, twice a day, for 13 weeks
Placebo Oral Capsule	Placebo Oral Capsule	10 mg placebo capsule, twice a day, for 13 weeks

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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

Trial Locations

Locations (12)

Pacific Treatment and Research Center; 🇺🇸 La Jolla, California, United States

Pharmacology Research Institute; 🇺🇸 Newport Beach, California, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Meridien Research; 🇺🇸 Lakeland, Florida, United States

Altea Research Institute; 🇺🇸 Las Vegas, Nevada, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Neuro-Behavioral Clinical Research Inc.; 🇺🇸 Canton, Ohio, United States

CODA, Inc.; 🇺🇸 Portland, Oregon, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Behavioral Clinical Research, Inc.; 🇺🇸 North Miami, Florida, United States

Matrix Institute on Addictions; 🇺🇸 Los Angeles, California, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States