Total Lorazepam Dosage (in Milligrams)
| Group | Value (milligrams of lorazepam) | Spread |
|---|---|---|
| Intranasal Spray Without Oxytocin | 16.5 | 4.4 |
| Intranasal Oxytocin Spray | 3.4 | 4.7 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Placebo comparator
intranasal spray without oxytocin
Twice daily intranasal spray without oxytocin.
Experimental
intranasal oxytocin spray
Twice daily intranasal oxytocin spray
Outcomes the sponsor listed as primary.
Total Lorazepam Dosage (in Milligrams)
Time frame · Days 1 to 5
Total lorazepam (in milligrams) required per subject to complete detoxification
CIWA-Ar Scores
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (milligrams of lorazepam) | Spread |
|---|---|---|
| Intranasal Spray Without Oxytocin | 16.5 | 4.4 |
| Intranasal Oxytocin Spray | 3.4 | 4.7 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Spray Without Oxytocin | 11.8 | 0.4 |
| Intranasal Oxytocin Spray | 4.3 | 2.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Intranasal Spray Without OxytocinTwice daily intranasal spray without oxytocin. intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily | – | 0 / 6 | 0 / 6 |
| Intranasal Oxytocin SprayTwice daily intranasal oxytocin spray intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days | – | 0 / 8 | 0 / 8 |
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