Oxytocin for Couples Conflict Resolution

NCT02941692 | Completed Phase 2 Results DMC

• 2 other identifiers: 31736K12HD055885
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Misuse; Interpersonal Conflict; Neuroendocrine Reactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oxytocin DRUG

Also known as: Pitocin

Oxytocin

Placebo DRUG

Placebo for Oxytocin

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Julianne Flanagan
• Organization: Medical University of South Carolina

Hellmuth@musc.edu

843-792-5569

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 21, 2016
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-09