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临床试验/NCT02941692
NCT02941692已完成2 期

The Effects of Oxytocin on Couples Conflict Resolution Interactions

Medical University of South Carolina0 个研究点目标入组 66 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
66
主要终点
Change in Frequency of Distress Maintaining Attributions

研究概览

简要总结

Oxytocin is a promising new medication found to have positive effects on prosocial behavior, reduce negative affect such as fear and anxiety, and reduce stress-induced addictive behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal oxytocin improves couples' conflict resolution skills and subjective, physiological, and neuroendocrine responses to conflict. Conflict resolution discussions will take place in the laboratory and will be videotaped.

详细描述

Substance use disorders (SUD) are characterized by dysregulation of the hypothalamic-pituitary axis (HPA). The neuropeptide oxytocin, commonly administered as an intranasal spray, is a drug that has prominent anxiolytic and prosocial effects on human behaviors. While the mechanisms of action facilitating the behavioral effects of oxytocin in humans is complex and many questions about this process remain, there is a consensus in the existing literature that oxytocin modulates HPA axis reactivity to stressful social stimuli. Preliminary studies suggest that oxytocin is known to reduce couple conflict among normative couples. A more developed line of research indicates that oxytocin mitigates addictive behaviors in the context of various drugs of abuse. Given the high prevalence and severity of dyadic conflict among couples where one or both partner has substance abuse, and given the salience of dyadic conflict as a precipitant to substance use behaviors, it is critical to investigate the therapeutic effects of oxytocin among couples with substance use problems. Namely, oxytocin holds promise as a potential augmenter for conjoint couples therapies, particularly those targeting the reduction of substance use problems. However, only two studies have examined the effects of oxytocin on couples' communication behaviors. Those two studies found that couples' communication skills improved following the administration of oxytocin. It is important to extend this line of research to examine conflict resolution skills among couples with substance use problems. To date, no studies have examined the effects of oxytocin on subjective, physiological, or neuroendocrine reactivity to dyadic conflict. The present study aims to fill that gap in the literature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of age
  • both partners are willing to participate, and
  • at least one partner has engaged in hazardous drinking (i.e. 4 or more drinks for women, 6 or more for men) or illicit drug use during the past 60 days

排除标准

  • pregnancy for women
  • current psychotic or bipolar disorders
  • active suicidal or homicidal ideation and intent
  • subjects who would present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study
  • severe, unilateral intimate partner violence in the past year
  • BMI greater than 39.

研究组 & 干预措施

Oxytocin

Experimental

Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Frequency of Distress Maintaining Attributions

时间窗: Frequency of distress maintaining attrbibutions per 10 minutes

Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions.

次要结局

  • Change in Salivary Cortisol (μg/dL)(Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2.)

研究者

申办方类型
Other
责任方
Sponsor

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