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Lorcaserin in the Treatment of Cocaine Use Disorder

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin
Placebo Oral Capsule
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pacific Treatment and Research Center
  • Matrix Institute on Addictions
  • Pharmacology Research Institute
  • George Washington University
  • Meridien Research
  • Behavioral Clinical Research, Inc.
  • Boston University School of Medicine
  • Altea Research Institute
  • Hassman Research Institute
  • Neuro-Behavioral Clinical Research Inc.
  • University of Cincinnati
  • CODA, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lorcaserin

Placebo Oral Capsule

Arm Description

10 mg capsule by mouth, twice a day, for 13 weeks

10 mg placebo capsule, twice a day, for 13 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2016
Last Updated
July 24, 2020
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03007394
Brief Title
Lorcaserin in the Treatment of Cocaine Use Disorder
Official Title
Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lorcaserin
Arm Type
Active Comparator
Arm Description
10 mg capsule by mouth, twice a day, for 13 weeks
Arm Title
Placebo Oral Capsule
Arm Type
Placebo Comparator
Arm Description
10 mg placebo capsule, twice a day, for 13 weeks
Intervention Type
Drug
Intervention Name(s)
Lorcaserin
Other Intervention Name(s)
Belviq, lorcaserin hydrochloride
Intervention Description
Lorcaserin Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Intervention Description
sugar pill to mimic lorcaserin 10mg capsule
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Treatment weeks 11 - 13
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shwe Gyaw, MD
Organizational Affiliation
National Institute on Drug Abuse (NIDA)
Official's Role
Study Chair
Facility Information:
Facility Name
Pacific Treatment and Research Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92307
Country
United States
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90016
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660-2452
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2391
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Neuro-Behavioral Clinical Research Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
CODA, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lorcaserin in the Treatment of Cocaine Use Disorder

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