Change in Craving to Use Alcohol Rating (Visual Analog Scale)
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin | 0.076 | 1.77 |
| Placebo | -0.928 | 1.42 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
NCT0274253220 Apr 2017 to 1 Jul 2019
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine whether oxytocin will decrease craving to use drugs/alcohol and stress reactivity following exposure to laboratory-induced stress among Active Duty Service Members with a dual diagnosis of alcohol/substance use disorder (ASUD) and post-traumatic anxiety.
Experimental
Oxytocin
Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)
Placebo comparator
Placebo
Intra-nasal saline placebo (5 puffs in each nostril)
Outcomes the sponsor listed as primary.
Change in Craving to Use Alcohol Rating (Visual Analog Scale)
Time frame · Change from baseline to post-drug at 20 minutes
The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher cravings.
Change in Stress Rating (Visual Analog Scale)
Time frame · Change from baseline to post-drug at 20 minutes
The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher stress.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin | 0.076 | 1.77 |
| Placebo | -0.928 | 1.42 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Oxytocin | -0.755 | 1.24 |
| Placebo | -1.268 | 1.82 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinIntra-nasal oxytocin (40 IUs; 5 puffs in each nostril) Oxytocin: Intranasal oxytocin 40 IU | 0 / 31 | 0 / 31 | 0 / 31 |
| PlaceboIntra-nasal saline placebo (5 puffs in each nostril) Placebo: Intranasal saline solution | 0 / 32 | 0 / 32 | 0 / 32 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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