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.

• Lorcaserin (Drug), also known as Belviq, lorcaserin hydrochloride: Lorcaserin Capsule
• Placebo Oral Capsule (Drug): sugar pill to mimic lorcaserin 10mg capsule

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 [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 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 [Treatment weeks 11-13]

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• 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 (Primary), Number, participants: Lorcaserin 1; Placebo Oral Capsule 4
• 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 (Secondary), Number, participants: Lorcaserin 0; Placebo Oral Capsule 3

Adverse events

Time frame: Adverse event data were collected every week during treatment and through study follow-up, a 13-week treatment phase with a 4-week follow-up period.

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2017-04-17)

• Shwe Gyaw, MD, Study chair, National Institute on Drug Abuse (NIDA)