Phase 2 N=66 Randomized Double-blind Other

Oxytocin for Couples Conflict Resolution

Substance Misuse · Interpersonal Conflict · Neuroendocrine Reactivity

Bottom Line

View on ClinicalTrials.gov: NCT02941692 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Change in Frequency of Distress Maintaining Attributions — .81; -.48 distress maintaining attributions

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oxytocin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Frequency of Distress Maintaining Attributions	.81; -.48	—
SECONDARY Change in Salivary Cortisol (μg/dL)	.28; .30; .25; .29; .18; .21	—

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.

Eligibility Criteria

Inclusion Criteria

18-65 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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02941692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.