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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: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01212185 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total lorazepam (in milligrams) required per subject to complete detoxification
Interventions
- DRUG intranasal oxytocin spray
- OTHER intranasal spray without oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01212185 record still lists
NCT01212185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which intranasal oxytocin spray is the first listed.
NCT01212185 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01212185's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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