Lorcaserin in the Treatment of Cocaine Use Disorder
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| ClinicalTrials.gov Identifier: NCT03007394 |
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Recruitment Status :
Active, not recruiting
First Posted : January 2, 2017
Last Update Posted : July 11, 2018
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Sponsor:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
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Brief Summary:
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cocaine-Related Disorders | Drug: Lorcaserin Drug: Placebo Oral Capsule | Phase 2 |
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.
| 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 : | June 19, 2017 |
| Estimated Primary Completion Date : | October 2018 |
| Estimated Study Completion Date : | December 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
Primary Outcome Measures :
- The primary endpoint is the proportion 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.
Secondary Outcome Measures :
- The secondary endpoint is the proportion of subjects that successfully achieve abstinence from cocaine during the last three weeks of treatment in the subset of the PPEE population who are either Non-Drinkers or who are attempting alcohol abstinence [ 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.
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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 |
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
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
| Study Chair: | Shwe Gyaw, MD | National Institute on Drug Abuse (NIDA) |
| Responsible Party: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT03007394 History of Changes |
| Other Study ID Numbers: |
NIDA/VACSP #1033 |
| First Posted: | January 2, 2017 Key Record Dates |
| Last Update Posted: | July 11, 2018 |
| Last Verified: | July 2018 |
| 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 | |
Keywords provided by National Institute on Drug Abuse (NIDA):
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Cocaine Use Disorder |
Additional relevant MeSH terms:
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Disease Cocaine-Related Disorders Pathologic Processes Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |