Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

NCT ID: NCT03846505

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-16
• Study Completion Date: 2024-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Oxytocin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Pitocin; Saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Julianne Flanagan

Associate Professor, Department of Psychiatry and Behavioral Sciences, Addiction Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julianne Flanagan, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AA027212

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00082233

Identifier Type: -

Identifier Source: org_study_id