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NCT01137890 · ClinicalTrials.gov registry record · Phase 1

Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

A Phase 1 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT01137890: Completed Phase 1 study, sponsored by Johns Hopkins University.

NCT01137890 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01137890, a Phase 1 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

This is a residential pilot trial to evaluate the pharmacodynamic interaction between zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment of cocaine dependence.

Primary Outcome

VAQ measures the change in effect after dose administration. Participants rate 6 items ("Any Drug Effect", "Rush", "Good Effects", "Bad Effects", "Liking", \& "Desire for Cocaine") by pointing an arrow along a 100-point line anchored at either end with "none" (0) \& "extremely" (100). Each participant's score is equal to the sum of all 6 ratings, \& the mean of all participant's scores is reported across each condition. The VAQ is only administered to subjects in the zonisamide (Zon) condition (

Interventions

  • DRUG Placebo
  • DRUG Zonisamide
  • DRUG Cocaine Hydrochloride
  • BEHAVIORAL Neurocognitive and Performance Battery
  • BEHAVIORAL Smoking Assessments

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2010-06
Est. Completion 2013-08
Phase Phase 1
Johns Hopkins University

1,448 total trials

What the finished NCT01137890 record still lists

NCT01137890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01137890 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01137890 about?

NCT01137890 is a clinical study titled "Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse". This is a residential pilot trial to evaluate the pharmacodynamic interaction between zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment of cocaine dependence.

What is the current status of trial NCT01137890?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2010-06. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01137890?

The interventions under investigation include: Placebo (DRUG), Zonisamide (DRUG), Cocaine Hydrochloride (DRUG), Neurocognitive and Performance Battery (BEHAVIORAL), Smoking Assessments (BEHAVIORAL).

Who is sponsoring clinical trial NCT01137890?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01137890's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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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Source: ClinicalTrials.gov NCT01137890, the US trial registry maintained by the National Library of Medicine. NCT01137890 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.