Lorcaserin in the Treatment of Cocaine Use Disorder
Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
1 other identifier
interventional
272
1 country
12
Brief Summary
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2017
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 2, 2017
CompletedStudy Start
First participant enrolled
December 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedResults Posted
Study results publicly available
June 19, 2020
CompletedAugust 5, 2020
February 1, 2020
2 years
December 21, 2016
June 2, 2020
July 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Treatment weeks 11 - 13
Secondary Outcomes (1)
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
Treatment weeks 11-13
Study Arms (2)
Lorcaserin
ACTIVE COMPARATOR10 mg capsule by mouth, twice a day, for 13 weeks
Placebo Oral Capsule
PLACEBO COMPARATOR10 mg placebo capsule, twice a day, for 13 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contact site for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Pacific Treatment and Research Center
La Jolla, California, 92307, United States
Matrix Institute on Addictions
Los Angeles, California, 90016, United States
Pharmacology Research Institute
Newport Beach, California, 92660-2452, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Meridien Research
Lakeland, Florida, 33805, United States
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161, United States
Boston University School of Medicine
Boston, Massachusetts, 02118-2391, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Neuro-Behavioral Clinical Research Inc.
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45229, United States
CODA, Inc.
Portland, Oregon, 97214, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David McCann, Ph.D.
- Organization
- National Institute on Drug Abuse
Study Officials
- STUDY CHAIR
Shwe Gyaw, MD
National Institute on Drug Abuse (NIDA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2016
First Posted
January 2, 2017
Study Start
December 19, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 5, 2020
Results First Posted
June 19, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share