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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin for Couples Conflict Resolution

NCTNCT02941692 (opens ClinicalTrials.gov in a new tab)Other id31736Other idK12HD055885
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
66 participants (actual)
Sponsor
Medical University of South Carolina · Other
Design
Randomized · Double masking
Countries
Not stated
Start
Jun 2014
Primary completion
Mar 2017
Completion
Mar 2017
First posted
21 Oct 2016 (estimated)
Last update posted
12 Oct 2018
Conditions
Substance Misuse · Interpersonal Conflict · Neuroendocrine Reactivity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 2

    Oxytocin for Couples Conflict Resolution

    NCT02941692

    Jun 2014 to Mar 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Frequency of Distress Maintaining Attributions

    Time frame · Frequency of distress maintaining attrbibutions per 10 minutes

    Registry description

    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.

Secondary outcomes(1)

  1. Change in Salivary Cortisol (μg/dL)

    Time frame · 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.

    Registry description

    Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Frequency of distress maintaining attrbibutions per 10 minutes

Change in Frequency of Distress Maintaining Attributions

GroupValue (distress maintaining attributions)Spread
Oxytocin.812.67
Placebo-.482.51
Secondary and other outcome results(1)
Secondary outcomeMean· 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.

Change in Salivary Cortisol (μg/dL)

GroupValue (μg/dL)Spread
Oxytocin.28.18
Placebo.30.20

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinParticipants randomized to this condition will receive 40 IU dose of intranasal oxytocin. Oxytocin0 / 320 / 320 / 32
PlaceboParticipants randomized to this condition will receive a matching dose of intranasal saline spray as placebo. Placebo: Placebo for Oxytocin0 / 340 / 340 / 34

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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