Oxytocin for Couples Conflict Resolution

The Effects of Oxytocin on Couples Conflict Resolution Interactions

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.

Study Overview

• Status: Completed
• Conditions: Substance Misuse; Interpersonal Conflict; Neuroendocrine Reactivity
• Intervention / Treatment: Drug: Oxytocin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.	Drug: Oxytocin; Other Names: Pitocin
Placebo Comparator: Placebo; Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.	Drug: Placebo; Placebo for Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frequency of Distress Maintaining Attributions	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.	Frequency of distress maintaining attrbibutions per 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary Cortisol (μg/dL)	Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.	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.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 31736; K12HD055885 (U.S. NIH Grant/Contract)