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NCT02563769 · ClinicalTrials.gov registry record · Phase 1
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
A Phase 1 study, sponsored by Temple University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02563769: Completed Phase 1 study, sponsored by Temple University.
NCT02563769 is a Phase 1 study that has completed, run by Temple University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02563769, a Phase 1 study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.
Primary Outcome
Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs.
Interventions
- DRUG Placebo
- DRUG Clavulanic acid
- DRUG Intravenous cocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-10-24 |
| Est. Completion | 2018-05-25 |
| Phase | Phase 1 |
What the finished NCT02563769 record still lists
NCT02563769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02563769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02563769 about?
NCT02563769 is a clinical study titled "Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study". The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can ...
What is the current status of trial NCT02563769?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-10-24. Estimated completion is 2018-05-25.
What interventions are being tested in trial NCT02563769?
The interventions under investigation include: Placebo (DRUG), Clavulanic acid (DRUG), Intravenous cocaine (DRUG).
Who is sponsoring clinical trial NCT02563769?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02563769's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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