Phase 2 N=272 Randomized Triple-blind Treatment

Lorcaserin in the Treatment of Cocaine Use Disorder

Cocaine-Related Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03007394 ↗

Enrolled (actual)

272

Serious AEs

4.1%

Results posted

Jun 2020

Primary outcome: Primary: 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 — 1; 4 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lorcaserin (Drug); Placebo Oral Capsule (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute on Drug Abuse (NIDA)
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	1; 4	—
SECONDARY 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	0; 3	—

Summary

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

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT03007394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.