Lorcaserin in the Treatment of Cocaine Use Disorder

ID: NCT03007394
Status: Recruiting
Phase: Phase 2
Start Date: June 19, 2017
First Submitted: December 21, 2016
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: National Institute on Drug Abuse (NIDA)
Location: United States
Conditions: Cocaine-Related Disorders
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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.
Condition or disease Intervention/treatment Phase

Cocaine-Related Disorders

Drug: Lorcaserin
Other Names
Belviq lorcaserin hydrochloride
Drug: Placebo Oral Capsule
Other Names
Phase 2

Tracking Information

First Submitted DateDecember 21, 2016
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 19, 2017
Anticipated Completion DateDecember 01, 2018
Actual Primary Completion DateAugust 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current 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.

Original Primary Outcome Measures

Not Available

Current 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleLorcaserin in the Treatment of Cocaine Use Disorder
Official TitlePhase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
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.

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
272
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Cocaine-Related Disorders
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Lorcaserin

Lorcaserin Capsule

Other Names
Belviq
lorcaserin hydrochloride
Drug: Placebo Oral Capsule

sugar pill to mimic lorcaserin 10mg capsule

Other Names
Study Groups/Cohorts
Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks

Placebo Oral Capsule
10 mg placebo capsule, twice a day, for 13 weeks

Study Arms
Active Comparator Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks
Drug : Lorcaserin
Lorcaserin Capsule

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

Arm Intervention/Treatment
Active Comparator Lorcaserin
10 mg capsule by mouth, twice a day, for 13 weeks
Drug : Lorcaserin
Placebo Comparator Placebo Oral Capsule
10 mg placebo capsule, twice a day, for 13 weeks
Drug : Placebo Oral Capsule

Recruitment Information

Recruitment Status:Recruiting
Enrollment272
Completion DateDecember 01, 2018
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
GenderAll
Age18 Years to 65 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03007394
Other Study ID Numbers
NIDA/VACSP #1033
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Not Available
Investigators
Study Chair
Shwe Gyaw, MD
National Institute on Drug Abuse (NIDA)