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.

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.

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:

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