Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

January 27, 2025 updated by: Julianne Flanagan, Medical University of South Carolina
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Male or female; any race or ethnicity; aged 18-75 years.
  2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (> 26 on the Mini-Mental State Exam).
  3. Married, cohabiting, or in a committed relationship for ≥ 6 months.
  4. Identified Patients (IPs) must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for current alcohol use disorder. Couples in which both partners meet diagnostic criteria for current Alcohol Use Disorder (AUD) are eligible for participation.
  5. Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice.
  6. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.

Exclusion criteria

  1. Meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those individuals will be referred clinically for treatment.
  2. Participants who present a serious suicide risk or are likely to require hospitalization during the study.
  3. Participants on psychotropic medications which have been initiated during the past 4 weeks. They may be re-assessed after at least four weeks on a stable dose.
  4. Acute alcohol withdrawal as indicated by Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores >8. They may be re-assessed once they are no longer in withdrawal. Those individuals will be referred for medically supervised detoxification.
  5. Severe unilateral intimate partner violence in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2).
  6. Pregnancy or breastfeeding for women.
  7. Individuals with implanted metal devices above the waist will be eligible to enroll in the clinical trial but will not be eligible to participate in the neuroimaging component of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin

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

All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.
Drug: Oxytocin
A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Other Names:
  • Pitocin
Placebo Comparator: Placebo

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

All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.
Other: Placebo
A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)
Time Frame: Baseline to week 12

Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes.

Time Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month).
Baseline to week 12
Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)
Time Frame: Baseline to week 12
Change in relationship functioning was measured by the Dyadic Adjustment Scale - Short Form (DAS-7), 7-item Likert-type self-report measure assessing four relationship domains (satisfaction, intimacy, affective expression, and agreement). The DAS-7 was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0-36, with higher scores representing better relationship functioning.
Baseline to week 12
Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)
Time Frame: Baseline to week 12
Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent heavy drinking days defined in a sex-specific manner (> 4 standard drinks for women or > 5 for men) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of heavy drinking days representing better outcomes.
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Julianne Flanagan, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2019

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

February 17, 2019

First Submitted That Met QC Criteria

February 17, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00082233
  • 1R01AA027212 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Use Disorder

Clinical Trials on Oxytocin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe