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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 is a Phase 4 study of Alcohol Withdrawal Syndrome that has completed, run by Mayo Clinic. The registered enrollment target is 88 participants. The trial reports 1 study location across 1 state.

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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.

Interventions

  • DRUG Gabapentin
  • DRUG Divalproex Sodium
  • DRUG Benzodiazepines

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2017-02-01
Est. Completion 2021-03-01
Phase Phase 4

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT03012815

The ClinicalTrials.gov registry entry for NCT03012815 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.