Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2017-12-19
2019-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks
Lorcaserin
Lorcaserin Capsule
Placebo Oral Capsule
10 mg placebo capsule, twice a day, for 13 weeks
Placebo Oral Capsule
sugar pill to mimic lorcaserin 10mg capsule
Interventions
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Lorcaserin
Lorcaserin Capsule
Placebo Oral Capsule
sugar pill to mimic lorcaserin 10mg capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Principal Investigators
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Shwe Gyaw, MD
Role: STUDY_CHAIR
National Institute on Drug Abuse (NIDA)
Locations
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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
George Washington University
Washington D.C., District of Columbia, United States
Meridien Research
Lakeland, Florida, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Altea Research Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Neuro-Behavioral Clinical Research Inc.
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
CODA, Inc.
Portland, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NIDA/VACSP #1033
Identifier Type: -
Identifier Source: org_study_id
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