CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 192 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03846505
NCT03846505Phase 2Completed

Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

Medical University of South Carolina·interventional·Posted Feb 19, 2019·Updated Feb 21, 2025

In Brief

A Phase 2 clinical trial evaluating Oxytocin and Placebo for Alcohol Use Disorder and Couples. Completed, enrolled 192 participants across 1 site.

Detailed Summary

Alcohol Behavioral Couples Therapy (ABCT) is a manualized 12-session, weekly psychosocial intervention that simultaneously reduces alcohol use disorder (AUD) severity and improves relationship functioning. However, there remains room to improve ABCT outcomes. A growing literature suggests that intranasal oxytocin is a medication that holds promise to achieve that goal. Oxytocin has demonstrated the ability to increase prosocial behavior (e.g., trust, safety, social cognition) and restore sensitivity to natural rewards such as interpersonal relationships that are commonly eroded in the context of addiction. Oxytocin has also demonstrated the ability to reduce substance use behaviors (e.g., craving, self-administration, tolerance, withdrawal), and improves the neurobiological foundations of AUD. The primary objective of this Stage II study is to test the efficacy of oxytocin versus placebo in improving (1) AUD symptom severity, (2) relationship functioning, and (3) corticolimbic connectivity among couples receiving ABCT therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 19, 2019
Enrollment StartMay 16, 2019
Primary CompletionJan 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.4 years ago

Interventions

Oxytocindrug

A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.

Placeboother

A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.