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NCT01212185 · ClinicalTrials.gov registry record · Phase 1

Oxytocin Treatment of Alcohol Withdrawal

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01212185 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants.

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The verdict

NCT01212185, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring standard medication treatment (lorazepam) and the amount of lorazepam required to control withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of subject recruitment and retention in the inpatient setting. Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical detoxification. Procedures (methods): Subjects will be inpatients undergoing medical detoxification from alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a randomized, double blind manner for three days. Withdrawal symptoms will be measured routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever withdrawal symptoms increase above specific parameters.

Interventions

  • DRUG intranasal oxytocin spray
  • OTHER intranasal spray without oxytocin

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2010-07
Est. Completion 2011-03
Phase Phase 1

What the Registry Record Tells You About NCT01212185

The ClinicalTrials.gov registry entry for NCT01212185 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which intranasal oxytocin spray is the first listed.

NCT01212185 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01212185 about?

NCT01212185 is a clinical study titled "Oxytocin Treatment of Alcohol Withdrawal". Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring standard medication treatment (lorazepam) and the amount of lorazepam required to control withdrawal bouts in individuals...

What is the current status of trial NCT01212185?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2010-07. Estimated completion is 2011-03.

What interventions are being tested in trial NCT01212185?

The interventions under investigation include: intranasal oxytocin spray (DRUG), intranasal spray without oxytocin (OTHER).

Who is sponsoring clinical trial NCT01212185?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

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.