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NCT04084860 · ClinicalTrials.gov registry record · Phase 2
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT04084860: Recruiting Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT04084860 is a Phase 2 study that is actively recruiting participants, run by New York State Psychiatric Institute. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04084860, a Phase 2 study, is actively recruiting participants, sponsored by New York State Psychiatric Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.
Primary Outcome
Defined as \>4 drinks/day for men; \>3 drinks for women. Comparing this outcome between groups that receive CI-581a versus CI-581b, as well as between CI-581a groups.
Interventions
- DRUG CI-581a
- DRUG CI-581b
- BEHAVIORAL MET
- BEHAVIORAL MBRP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 2 |
What NCT04084860 shows while recruiting
NCT04084860 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which CI-581a is the first listed.
NCT04084860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04084860 about?
NCT04084860 is a clinical study titled "The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking". The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 fa...
What is the current status of trial NCT04084860?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-11-08. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT04084860?
The interventions under investigation include: CI-581a (DRUG), CI-581b (DRUG), MET (BEHAVIORAL), MBRP (BEHAVIORAL).
Who is sponsoring clinical trial NCT04084860?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04084860's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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