Lorcaserin in the Treatment of Cocaine Use Disorder

Cocaine-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007394
• Other study ID #: NIDA/VACSP #1033
• Status: Completed
• Phase: Phase 2
• Start date: December 19, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2020
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease

Intervention

Drug:
• Lorcaserin
Lorcaserin Capsule
• Placebo Oral Capsule
sugar pill to mimic lorcaserin 10mg capsule

Locations

Country	Name	City	State
United States	Hassman Research Institute	Berlin	New Jersey
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Neuro-Behavioral Clinical Research Inc.	Canton	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Pacific Treatment and Research Center	La Jolla	California
United States	Meridien Research	Lakeland	Florida
United States	Altea Research Institute	Las Vegas	Nevada
United States	Matrix Institute on Addictions	Los Angeles	California
United States	Pharmacology Research Institute	Newport Beach	California
United States	Behavioral Clinical Research, Inc.	North Miami	Florida
United States	CODA, Inc.	Portland	Oregon
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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