Lorcaserin in the Treatment of Cocaine Use Disorder

National Institute on Drug Abuse (NIDA)272 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

272

Conditions

Cocaine-Related Disorders

Interventions

LorcaserinDRUG

Lorcaserin Capsule

Placebo Oral CapsuleDRUG

sugar pill to mimic lorcaserin 10mg capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (12)

Pacific Treatment and Research Center

La Jolla, California, United States

Matrix Institute on Addictions

Los Angeles, California, United States

Pharmacology Research Institute

Newport Beach, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Treatment weeks 11 - 13

Secondary Outcomes

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

Data from ClinicalTrials.gov

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