Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
研究概览
简要总结
The purpose of this research is to study the effects of nasal oxytocin administration on maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with prenatal use of cocaine during the current pregnancy will be studied at 3-6 months postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected is confidential.
详细描述
Participation for mothers when they are 3-6 months postpartum includes:
- Visit 1: Questionnaires and interviews about participants' health, pregnancy, moods, psychological history and drug use during pregnancy and postpartum.
- Visit 2: Pregnancy & drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, instruction re: using nasal spray (oxytocin or placebo) & self-administration of first nasal spray dose, followed by 90 minutes of monitoring.
- At-home nasal spray: Twice daily (before breakfast and supper) nasal spray self-administration for 14 days.
- Visit 3: Pregnancy & drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, interviews and questionnaires about mothers' experience with the nasal spray, and changes in mood or physical discomfort during the 2-weeks when taking the nasal spray.
- 3 telephone interviews while subjects are taking nasal spray, and 1 post-trail telephone follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •3-6 months postpartum at start of testing
- •Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology)
- •Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk)
- •Healthy singleton pregnancy
- •English fluency that will allow informed consent
排除标准
- •Pregnancy or plans to become pregnant during participation in the study
- •Not using effective birth control methods to prevent pregnancy
- •Breastfeeding for any infant milk feedings
- •Mother is not currently living with the infant during the trial period
- •Multiple birth (twin, triplet or greater)
研究组 & 干预措施
Syntocinon treatment
Syntocinon spray, 24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).
干预措施: Syntocinon treatment (Drug)
Placebo
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
干预措施: Placebo (Other)
结局指标
主要结局
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
时间窗: 2 weeks
次要结局
- The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by self-reported affective ratings.(2 weeks)
- The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in vascular resistance from pre- to post-test nasal spray.(2 weeks)
- The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in plasma norepinephrine.(2 weeks)