Clinical trial NCT03007394: Lorcaserin in the Treatment of Cocaine Use Disorder
Official title: Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2017-01-02
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Treatment weeks 11 - 13
Secondary outcomes:
measure: 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
timeFrame: Treatment weeks 11-13
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Pacific Treatment and Research Center
state: California
city: Los Angeles
country: United States
facility: Matrix Institute on Addictions
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: CODA, Inc.
state: Oregon
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Shwe Gyaw, MD
role: STUDY_CHAIR
References: