Lorcaserin in the Treatment of Cocaine Use Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03007394 |
Recruitment Status :
Completed
First Posted : January 2, 2017
Results First Posted : June 19, 2020
Last Update Posted : August 5, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cocaine-Related Disorders | Drug: Lorcaserin Drug: Placebo Oral Capsule | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 272 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder |
Actual Study Start Date : | December 19, 2017 |
Actual Primary Completion Date : | December 1, 2019 |
Actual Study Completion Date : | December 1, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks
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Drug: Lorcaserin
Lorcaserin Capsule
Other Names:
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Placebo Comparator: Placebo Oral Capsule
10 mg placebo capsule, twice a day, for 13 weeks
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Drug: Placebo Oral Capsule
sugar pill to mimic lorcaserin 10mg capsule |
- 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 [ Time Frame: 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.
- 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 [ Time Frame: Treatment weeks 11-13 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007394
United States, California | |
Pacific Treatment and Research Center | |
La Jolla, California, United States, 92307 | |
Matrix Institute on Addictions | |
Los Angeles, California, United States, 90016 | |
Pharmacology Research Institute | |
Newport Beach, California, United States, 92660-2452 | |
United States, District of Columbia | |
George Washington University | |
Washington, District of Columbia, United States, 20052 | |
United States, Florida | |
Meridien Research | |
Lakeland, Florida, United States, 33805 | |
Behavioral Clinical Research, Inc. | |
North Miami, Florida, United States, 33161 | |
United States, Massachusetts | |
Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118-2391 | |
United States, Nevada | |
Altea Research Institute | |
Las Vegas, Nevada, United States, 89102 | |
United States, New Jersey | |
Hassman Research Institute | |
Berlin, New Jersey, United States, 08009 | |
United States, Ohio | |
Neuro-Behavioral Clinical Research Inc. | |
Canton, Ohio, United States, 44718 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45229 | |
United States, Oregon | |
CODA, Inc. | |
Portland, Oregon, United States, 97214 |
Study Chair: | Shwe Gyaw, MD | National Institute on Drug Abuse (NIDA) |
Documents provided by National Institute on Drug Abuse (NIDA):
Responsible Party: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT03007394 |
Other Study ID Numbers: |
NIDA/VACSP #1033 |
First Posted: | January 2, 2017 Key Record Dates |
Results First Posted: | June 19, 2020 |
Last Update Posted: | August 5, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cocaine Use Disorder |
Disease Cocaine-Related Disorders Pathologic Processes |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |