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Trial record 2 of 465 for:    Alcohol* OR Cocaine OR Shizophrenia OR social | Studies received from 08/01/2016 to 01/16/2017

Lorcaserin in the Treatment of Cocaine Use Disorder

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by National Institute on Drug Abuse (NIDA)
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT03007394
First received: December 21, 2016
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.

Condition Intervention Phase
Cocaine-Related Disorders Drug: Lorcaserin Drug: Placebo Oral Capsule Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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.


Estimated Enrollment: 272
Actual Study Start Date: June 19, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03007394

Contacts
Contact: Liza Zeinert 301-443-1138 liza.zeinert@nih.gov

Locations
United States, California
Pacific Treatment and Research Center Recruiting
La Jolla, California, United States, 92307
Contact: Robert Anthenelli, MD    858-534-9458    ranthenelli@ucsd.edu   
Matrix Institute on Addictions Recruiting
Los Angeles, California, United States, 90016
Contact: Daniel George, MPH    323-933-9186    dgeorge@matrixinstitute.org   
Pharmacology Research Institute Recruiting
Newport Beach, California, United States, 92660-2452
Contact: Nadar Oskooilar, MD    949-752-7910    noskooilar@priresearch.com   
United States, District of Columbia
George Washington University Recruiting
Washington, D.C., District of Columbia, United States, 20052
Contact: Debra Bernat, PhD    202-994-2443    dbernat@gwu.edu   
United States, Florida
Meridien Research Recruiting
Lakeland, Florida, United States, 33805
Contact: James Andersen, MD    863-940-2087    jandersen@meridienresearch.net   
Behavioral Clinical Research, Inc. Recruiting
North Miami, Florida, United States, 33161
Contact: Olga M Lapeyra, MD, CCRP    305-722-8444 ext 2248    olapeyra@behavioralclinical.com   
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118-2391
Contact: Eric Devine, PhD    617-638-7888    eric.devine@bmc.org   
United States, Nevada
Altea Research Institute Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Jelena Kunovac, MD    702-527-7401    DrK@kunovacmd.com   
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Contact: Howard Hassman, DO    856-753-7335 ext 350    hhassman@hritrials.com   
United States, Ohio
Neuro-Behavioral Clinical Research Inc. Recruiting
Canton, Ohio, United States, 44718
Contact: Shishuka Malhotra, MD    330-493-1118    smalhotra@nb.cr.com   
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Theresa Winhusen, PhD    513-585-8292    winhust@ucmail.uc.edu   
United States, Oregon
CODA, Inc. Recruiting
Portland, Oregon, United States, 97214
Contact: Katharina Wiest, PhD    971-202-7749    katharinawiest@codainc.org   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Study Chair: Shwe Gyaw, MD National Institute on Drug Abuse (NIDA)
  More Information

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03007394     History of Changes
Other Study ID Numbers: NIDA/VACSP #1033
Study First Received: December 21, 2016
Last Updated: June 29, 2017
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):
Cocaine Use Disorder

Additional relevant MeSH terms:
Cocaine-Related Disorders
Cocaine
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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

ClinicalTrials.gov processed this record on July 21, 2017