Trial · NCT01212185
Oxytocin Treatment of Alcohol Withdrawal
NCT01212185, Phase 1, Completed, University of North Carolina, Chapel Hill; results first posted 2014-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oxytocin Treatment of Alcohol Withdrawal. Trials, record NCT01212185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01212185
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxytocin Treatment of Alcohol Withdrawal
- NCT number
- NCT01212185
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Alcohol Withdrawal
- Interventions
- intranasal oxytocin spray, intranasal spray without oxytocin
- First posted
- 2010-09-30
- Last updated
- 2014-05-13
- Results first posted
- 2014-05-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Lorazepam Dosage (in Milligrams) | Days 1 to 5 | Total lorazepam (in milligrams) required per subject to complete detoxification |
| Secondary | CIWA-Ar Scores | days 1 | Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Lorazepam Dosage (in Milligrams) | Days 1 to 5 | milligrams of lorazepam | MEAN | |
| SECONDARY | CIWA-Ar Scores | days 1 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Lorazepam Dosage (in Milligrams) | Intranasal Spray Without Oxytocin | 16.5 | Standard Deviation 4.4 | milligrams of lorazepam | |
| Total Lorazepam Dosage (in Milligrams) | Intranasal Oxytocin Spray | 3.4 | Standard Deviation 4.7 | milligrams of lorazepam | |
| CIWA-Ar Scores | Intranasal Spray Without Oxytocin | 11.8 | Standard Deviation 0.4 | units on a scale | |
| CIWA-Ar Scores | Intranasal Oxytocin Spray | 4.3 | Standard Deviation 2.3 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intranasal Spray Without Oxytocin | 6 | |
| Overall Study | STARTED | Intranasal Oxytocin Spray | 8 | |
| Overall Study | COMPLETED | Intranasal Spray Without Oxytocin | 4 | |
| Overall Study | COMPLETED | Intranasal Oxytocin Spray | 7 | |
| Overall Study | NOT COMPLETED | Intranasal Spray Without Oxytocin | 2 | |
| Overall Study | NOT COMPLETED | Intranasal Oxytocin Spray | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | electrolyte abnormalities | Endocrine disorders | Intranasal Spray Without Oxytocin | 0 | 6 | 0 |
| serious | electrolyte abnormalities | Endocrine disorders | Intranasal Oxytocin Spray | 0 | 8 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Spray Without Oxytocin | ||
| Total, all-cause mortality | Intranasal Oxytocin Spray | ||
| Total, other adverse events | Intranasal Spray Without Oxytocin | 0 | 6 |
| Total, other adverse events | Intranasal Oxytocin Spray | 0 | 8 |
| Total, serious adverse events | Intranasal Spray Without Oxytocin | 0 | 6 |
| Total, serious adverse events | Intranasal Oxytocin Spray | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intranasal Spray Without Oxytocin vs Intranasal Oxytocin Spray: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01212185
GET https://conductscience.org/api/trials/v1/NCT01212185/registered