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Lorcaserin in the Treatment of Cocaine Use Disorder

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ClinicalTrials.gov Identifier: NCT03007394
Recruitment Status : Active, not recruiting
First Posted : January 2, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Study Description
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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

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.

Study Design
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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 : March 2019
Estimated Study Completion Date : May 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks
 Drug: Lorcaserin
Lorcaserin Capsule
Other Names:
  • Belviq
  • lorcaserin hydrochloride
Placebo Comparator: Placebo Oral Capsule
10 mg placebo capsule, twice a day, for 13 weeks
 Drug: Placebo Oral Capsule
sugar pill to mimic lorcaserin 10mg capsule


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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
Contacts and Locations
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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
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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
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Study Chair: Shwe Gyaw, MD National Institute on Drug Abuse (NIDA)
More Information
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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: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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):
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