Lorcaserin in the Treatment of Cocaine Use Disorder

Study Overview
=================
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.

Official Title
-----------------
Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Lorcaserin
* Drug: Placebo Oral Capsule


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lorcaserin<br>10 mg capsule by mouth, twice a day, for 13 weeks | Drug: Lorcaserin<br>* Lorcaserin Capsule<br>* Other names: lorcaserin hydrochloride;|
| Placebo Comparator: Placebo Oral Capsule<br>10 mg placebo capsule, twice a day, for 13 weeks | Drug: Placebo Oral Capsule<br>* sugar pill to mimic lorcaserin 10mg capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Use Disorder