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Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder

NCT02537873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-05-12

Study results available
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Summary

The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with cocaine) and efficacy (subjective response to cocaine and self administration data) in non-treatment seeking cocaine use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. Lorcaserin and other 5-HT2CR agonists have been shown to reduce cocaine self-administration and cue reactivity in rodents. In addition there is human safety data in non-cocaine using subjects for lorcaserin as it is currently FDA approved for obesity, and safety data from a cocaine interaction study in rodents , but there is no human cocaine interaction/PK data and no PD data to support potential dosages for phase II clinical trials.

Conditions

  • Cocaine Use Disorder

Interventions

DRUG

Lorcaserin

Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)

DRUG

Cocaine Intravenous (IV)

Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions

DRUG

Placebo comparator

Dextrose in gelatin capsule

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Frederick G Moeller, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-07-19
Completion
2018-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02537873 on ClinicalTrials.gov