Clinical trial NCT02941692: Oxytocin for Couples Conflict Resolution
Official title: The Effects of Oxytocin on Couples Conflict Resolution Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Misuse
Interpersonal Conflict
Neuroendocrine Reactivity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-10-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 18-65 years of age
2. both partners are willing to participate, and
3. 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

Exclusion Criteria:

1. pregnancy for women
2. current psychotic or bipolar disorders
3. active suicidal or homicidal ideation and intent
4. 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
5. severe, unilateral intimate partner violence in the past year
6. BMI greater than 39.

Primary outcomes:
measure: Change in Frequency of Distress Maintaining Attributions
timeFrame: Frequency of distress maintaining attrbibutions per 10 minutes
Secondary outcomes:
measure: Change in Salivary Cortisol (μg/dL)
timeFrame: 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.
Other outcomes:
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