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NCT02901041 · ClinicalTrials.gov registry record · Phase 3
Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
A Phase 3 study, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
NCT02901041 is a Phase 3 study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 81 participants.
The verdict
NCT02901041, a Phase 3 study, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
Study Summary
Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000 deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however, approved medications for the treatment of AUD has shown limited effectiveness. Zonisamide (ZON), a broad spectrum anticonvulsant, has proven to be more effective than a placebo in reducing alcohol intake in individuals with alcohol dependence. ZON's mechanism of action seems to be quite distinct from currently approved anti-alcoholism medications, which holds promise for treatment of individuals who are not responsive to conventional medications. However, much remains unknown about ZON's therapeutic mechanisms and ZON's efficacy in treating patients with a diagnosis of AUD. To fill in these gaps, the investigators will conduct a double-blind randomized controlled study that assesses ZON's treatment mechanisms and effectiveness in reducing alcohol consumption in patients with AUD. Participants will be randomized to one of two conditions: 1) treatment with ZON and a computerized psychotherapy platform called Take Control (TC); 2) treatment with a placebo (PLC) and TC. To understand the neurobiology behind ZON's potential therapeutic effects on AUD, fMRI will be used to compare the brain activity of the ZON+TC versus PLC+TC group while participants perform an alcohol and emotional-word Stroop task, as well as an alcohol related cues task.
Interventions
- BEHAVIORAL Take Control
- DRUG Zonisamide
- DRUG Placebo (for Zonisamide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2017-09-21 |
| Est. Completion | 2022-01-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02901041
The ClinicalTrials.gov registry entry for NCT02901041 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Take Control is the first listed.
NCT02901041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02901041 about?
NCT02901041 is a clinical study titled "Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism". Alcoholism is the third leading cause of preventable death in the US, accounting for 80,000 deaths annually. Almost 18 million US adults have alcohol use disorder (AUD); however, approved medications for the treatment of AUD has shown limited effectiveness. Zonisamide (ZON), a broad spectrum antico...
What is the current status of trial NCT02901041?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2017-09-21. Estimated completion is 2022-01-04.
What interventions are being tested in trial NCT02901041?
The interventions under investigation include: Take Control (BEHAVIORAL), Zonisamide (DRUG), Placebo (for Zonisamide) (DRUG).
Who is sponsoring clinical trial NCT02901041?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
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