Oxytocin for Couples Conflict Resolution

NCT ID: NCT02941692

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-03-31

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.

Conditions

Substance Misuse; Interpersonal Conflict; Neuroendocrine Reactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

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

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for Oxytocin

Interventions

Oxytocin

Intervention Type: DRUG

Placebo

Placebo for Oxytocin

Intervention Type: DRUG

Other Intervention Names

Pitocin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K12HD055885

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31736

Identifier Type: -

Identifier Source: org_study_id