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Lorcaserin in the Treatment of Cocaine Use Disorder

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ClinicalTrials.gov Identifier: NCT03007394
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

December 21, 2016
January 2, 2017
March 2, 2018
June 19, 2017
August 2018   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT03007394 on ClinicalTrials.gov Archive Site
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.
The primary 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 also part of the Non-Drinker Population [ Time Frame: Treatment weeks 11-13 ]
Not Provided
Not Provided
 
Lorcaserin in the Treatment of Cocaine Use Disorder
Phase 2, Multi-Center Trial of 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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cocaine-Related Disorders
  • Drug: Lorcaserin
    Lorcaserin Capsule
    Other Names:
    • Belviq
    • lorcaserin hydrochloride
  • Drug: Placebo Oral Capsule
    sugar pill to mimic lorcaserin 10mg capsule
  • Active Comparator: Lorcaserin
    10 mg capsule by mouth, twice a day, for 13 weeks
    Intervention: Drug: Lorcaserin
  • Placebo Comparator: Placebo Oral Capsule
    10 mg placebo capsule, twice a day, for 13 weeks
    Intervention: Drug: Placebo Oral Capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
272
Same as current
December 2018
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact: Liza Zeinert 301-443-1138 liza.zeinert@nih.gov
United States
 
 
NCT03007394
NIDA/VACSP #1033
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Study Chair: Shwe Gyaw, MD National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP