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Completed

NCT Number: NCT03007394

Lorcaserin in the Treatment of Cocaine Use Disorder

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

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pacific Treatment and Research Center, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorcaserin

Drug

Lorcaserin Capsule

Other names: Belviq, lorcaserin hydrochloride

Placebo oral capsule

Drug

sugar pill to mimic lorcaserin 10mg capsule

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2017
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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