Results of a Randomized Controlled Trial Examining the Efficacy of Intranasal Oxytocin to Enhance Alcohol Behavioral Couple Therapy.

Objective

This study examined the efficacy of intranasal oxytocin (40 IU), compared to matching placebo (saline), when combined with Alcohol Behavioral Couple Therapy (ABCT) for the treatment of alcohol use disorder (AUD).

Methods

This 12-week clinical trial (2018-2024) utilized a double-blind, randomized, placebo-controlled design. Enrollment occurred from May 2019 to April 2023. Participants were romantic couples (N = 96 dyads; n = 49 oxytocin, n = 47 placebo) consisting of an identified patient (IP) with current AUD per DSM-5 and their partner. Dyads in which both partners had AUD were eligible, and both partners in each dyad were randomized to the same drug condition (ie, placebo or oxytocin). Participants were observed in their medication self-administration 30 minutes prior to ABCT therapy sessions. Primary outcome measures were alcohol consumption (percent days drinking and percent days heavy drinking; Time Line Follow-Back) and relationship functioning (Dyadic Adjustment Scale-Short Form).

Results

All IPs and 50% of partners met diagnostic criteria for AUD; 62 IPs (64.5%) met criteria for severe AUD. Findings from the intent-to-treat analyses indicate that IPs and partners in both conditions evidenced substantial improvements in alcohol consumption and alcohol problem severity but not relationship functioning. No group differences emerged in alcohol consumption, alcohol problem severity, or relationship functioning at end of treatment. Participants completed an average of 10.2 ABCT sessions (SD = 3.5). There were no group differences in the number of medication doses administered or adverse events.

Conclusions

Oxytocin was safe and tolerable but did not provide additional benefit beyond ABCT at the end of treatment. Alternative strategies are necessary to understand oxytocin's potential to facilitate different domains of AUD recovery. Trial Registration: ClinicalTrials.gov identifier: NCT03046836.