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NCT03430544 · ClinicalTrials.gov registry record · Phase 2
Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder
A Phase 2 study, sponsored by Anna Rose Childress, Ph.D..
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03430544: Clinical Trial Phase 2 study, sponsored by Anna Rose Childress, Ph.D..
NCT03430544 is a Phase 2 study that was terminated before completion, run by Anna Rose Childress, Ph.D.. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03430544, a Phase 2 study, was terminated before completion, sponsored by Anna Rose Childress, Ph.D..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpatients during fMRI sessions. After the 2-week inpatient/medication induction phase, study medication will continue for 8 outpatient weeks, during which time cocaine use will be tracked. Subjects will be monitored during a 4-wk followup phase thereafter.
Primary Outcome
The primary fMRI outcome is the extracted BOLD signal change during visual stimuli reminiscent of cocaine (i.e., cocaine cues) in an a priori circuit-level ROI.
Interventions
- DRUG Placebo oral capsule
- DRUG Cariprazine Oral Capsule [Vraylar]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-04-04 |
| Est. Completion | 2020-09-04 |
| Phase | Phase 2 |
Why NCT03430544 stopped before completion
NCT03430544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03430544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03430544 about?
NCT03430544 is a clinical study titled "Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder". This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpat...
What is the current status of trial NCT03430544?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-04-04. Estimated completion is 2020-09-04.
What interventions are being tested in trial NCT03430544?
The interventions under investigation include: Placebo oral capsule (DRUG), Cariprazine Oral Capsule [Vraylar] (DRUG).
Who is sponsoring clinical trial NCT03430544?
This trial is sponsored by Anna Rose Childress, Ph.D., which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03430544's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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