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NCT03012815 · ClinicalTrials.gov registry record · Phase 4
Gabapentin for Alcohol Withdrawal Syndrome
A Phase 4 study of Alcohol Withdrawal Syndrome, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT03012815: Completed Phase 4 study of Alcohol Withdrawal Syndrome, sponsored by Mayo Clinic.
NCT03012815 is a Phase 4 study of Alcohol Withdrawal Syndrome that has completed, run by Mayo Clinic. The registered enrollment target is 88 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03012815, a Phase 4 study of Alcohol Withdrawal Syndrome, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines. This method of treatment has several drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS, a study to compare gabapentin to symptom-triggered lorazepam will be completed.
Primary Outcome
The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are \<10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67.
Conditions Studied
Interventions
- DRUG Gabapentin
- DRUG Divalproex Sodium
- DRUG Benzodiazepines
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 4 |
What the finished NCT03012815 record still lists
NCT03012815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Alcohol Withdrawal Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Gabapentin is the first listed.
NCT03012815 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03012815 about?
NCT03012815 is a clinical study titled "Gabapentin for Alcohol Withdrawal Syndrome". The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines. This method of treatment has several drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have been evaluated for use in AWS...
What is the current status of trial NCT03012815?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2017-02-01. Estimated completion is 2021-03-01.
What conditions does trial NCT03012815 study?
This clinical trial studies the following conditions: Alcohol Withdrawal Syndrome.
What interventions are being tested in trial NCT03012815?
The interventions under investigation include: Gabapentin (DRUG), Divalproex Sodium (DRUG), Benzodiazepines (DRUG).
Who is sponsoring clinical trial NCT03012815?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03012815 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03012815's enrollment target sits among peer trials
88 916th of 2000 higher than 1,078 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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