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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: Completed Phase 3 study, sponsored by Boston University Charles River Campus.
NCT02901041 is a Phase 3 study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 81 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Timeline followback (TLFB) was used to collect information on participant's daily drinking. TLFB is a form of interview used to collect retroactive data related to participant's drinking. Participants are presented with a calendar are asked to report what they drank each day for a specified timeframe (e.g. in the past week). Participants were encouraged to give their best estimate in the absence of total certainty regarding their drinking on a given day. Study assessors then used these responses
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 |
What the finished NCT02901041 record still lists
NCT02901041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Take Control is the first listed.
NCT02901041 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02901041's enrollment target sits among peer trials
81 1752nd of 2000 higher than 246 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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