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NCT02537873 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder
A Phase 1 study of Cocaine Use Disorder, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT02537873 is a Phase 1 study of Cocaine Use Disorder that has completed, run by Virginia Commonwealth University. The registered enrollment target is 29 participants, below the 103-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02537873, a Phase 1 study of Cocaine Use Disorder, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
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
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 103-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (72% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT02537873 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
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.
What interventions are being tested in trial NCT02537873?
The interventions under investigation include: Placebo comparator (DRUG), Lorcaserin (DRUG), Cocaine Intravenous (IV) (DRUG).
Who is sponsoring clinical trial NCT02537873?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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