Salivary Cortisol Levels
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Oxytocin | 0.18 | 0.09 |
| Placebo | 0.22 | 0.09 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
NCT01963091Jul 2011 to Oct 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.
Experimental
oxytocin
Placebo comparator
placebo
Outcomes the sponsor listed as primary.
Salivary Cortisol Levels
Time frame · 0 minutes post 15 minute stress task
salivary cortisol
Likert Scale Rating of Subjective Stress
Time frame · 0 minutes post 15 minute stress task
Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
Likert Scale Rating of Subjective Craving
Time frame · 0 mintues post 15 minute stress task
Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Oxytocin | 0.18 | 0.09 |
| Placebo | 0.22 | 0.09 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 4.18 | 3.49 |
| Placebo | 4.25 | 2.93 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Oxytocin | 3.35 | 4.03 |
| Placebo | 3.13 | 2.80 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oxytocinoxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary. | – | 0 / 17 | 0 / 17 |
| Placebosaline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary. | – | 0 / 16 | 0 / 16 |
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