NCT03846505

Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder
• Couples

Interventions

Type	Name	Description
DRUG	Oxytocin	A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.
OTHER	Placebo	A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.

Timeline

• Start date: 2019-05-16
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2019-02-19
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study