Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Oxytocin Spray (Syntocinon Spray) | -2.76 | 1.95 |
| Intranasal Placebo Spray | 1.01 | 1.62 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name OT-ETOH2
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will test in individuals who have alcohol dependence (alcohol addiction) the hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the outpatient setting will decrease drinking.
Active comparator
Intranasal oxytocin spray (Syntocinon Spray)
TID inpatient; BID outpatient for 12 wks
Placebo comparator
Intranasal Placebo Spray
TID inpatient; BID outpatient for 12 wks
Outcomes the sponsor listed as primary.
Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score
Time frame · Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments
The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).
Total mg of Lorazepam for Detoxification
Time frame · 48 hours after initiation of intranasal test doses
Cumulative lorazepam received (2 mg doses) After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were \>7, diastolic blood pressure rose to \>120, or heart rate rose to \>110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated.
Change in Percentage Heavy Drinking Days
Time frame · 90 days prior to admission and 4 weeks in the outpatient setting
A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Oxytocin Spray (Syntocinon Spray) | -2.76 | 1.95 |
| Intranasal Placebo Spray | 1.01 | 1.62 |
| Group | Value (cumulative lorazepam doses (mg)) | Spread |
|---|---|---|
| Intranasal Oxytocin Spray (Syntocinon Spray) | 2.25 | 1.26 |
| Intranasal Placebo Spray | 5.25 | 2.5 |
| Group | Value (percentage of heavy drinking days change) | Spread |
|---|---|---|
| Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon) | -0.377 | 0.28 |
| Outpatient Treatment Placebo Spray | -0.972 | 0.032 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Intranasal Oxytocin Spray (Syntocinon Spray)Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray: Administration of oxytocin in a nasal spray | 0 / 5 | 0 / 5 | 0 / 5 |
| Intranasal Placebo SprayPlacebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray: Administration of oxytocin in a nasal spray Intranasal Placebo Spray: Intranasal Placebo Spray | 0 / 4 | 0 / 4 | 0 / 4 |
| Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)2 daily doses intranasal oxytocin spray for 12 weeks | 0 / 6 | 0 / 6 | 0 / 6 |
| Outpatient Treatment Placebo Spray2 daily doses intranasal placebo spray for 12 weeks | 0 / 3 | 0 / 3 | 0 / 3 |
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