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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007394
Other study ID # NIDA/VACSP #1033
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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