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COMPLETED Phase 1

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

NCT02537873 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo comparator
  • DRUG Lorcaserin
  • DRUG Cocaine Intravenous (IV)

Study Locations (1)

Virginia

  • Virginia Commonwealth University, Institute for Drug and Alcohol Studies — Richmond

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2015-07
Est. Completion 2018-07-19
Phase Phase 1

Sponsor

Virginia Commonwealth University

513 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02537873

The ClinicalTrials.gov registry entry for NCT02537873 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 513 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cocaine Use Disorder appearing as the primary indexed condition, and to 3 interventions — of which Placebo comparator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02537873 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02537873 about?

NCT02537873 is a clinical study titled "Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder". 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 ...

What is the current status of trial NCT02537873?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2015-07. Estimated completion is 2018-07-19.

What conditions does trial NCT02537873 study?

This clinical trial studies the following conditions: Cocaine Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02537873?

The interventions under investigation include: Placebo comparator (DRUG), Lorcaserin (DRUG), Cocaine Intravenous (IV) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02537873?

This trial is sponsored by Virginia Commonwealth University, which has 513 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02537873 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial