Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

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: Active, not recruiting
• Conditions: Alcohol Use Disorder; Couples
• Intervention / Treatment: Drug: Oxytocin; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Julianne Flanagan, PhD; Phone Number: 843-792-5569; Email: hellmuth@musc.edu

Study Locations

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

Participation Criteria

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 for ≥ 6 months, or in a committed relationship of at least 1-year duration.
4. ≥1 hazardous drinking episode in past 60 days by IP.
5. Identified Patients (IPs) must meet DSM-5 diagnostic criteria for current (i.e., past 6 months) alcohol use disorder. Couples in which both partners meet diagnostic criteria for current AUD are eligible for participation.
6. Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice.
7. 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. History of seizures and/or seizure disorder
4. Severe unilateral intimate partner violence in the past 6 months as defined by the CTS-2.
5. Pregnancy or breastfeeding
6. Acute alcohol withdrawal as indicated by 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.
7. Any unstable or serious medical condition affecting the potential participants' ability to participate in the study
8. Individuals with claustrophobia; tattoos above the shoulders; permanent eyeliner or permanent artificial eyebrows; cardiac pacemaker; metal fragments in eye, skin, or body, including shrapnel; heart valve replacement; brain clips; venous umbrella; current or former sheet-metal worker or welder; lifetime history of aneurysm surgery; lifetime history of seizures and/or epilepsy; intracranial bypass, renal, or aortic clips; prosthetic devices such as middle ear, eye, joint, or penile implants; joint replacements; non-removable hearing aid, neurostimulator, or insulin pump; shunts/stents; metal mesh/coil implants; metal plate/pin/screws/wires; or any other MRI contraindications as determined by the MRI technician at the time of scanning will not be eligible to participate in the neuroimaging component of the study, however individuals who meet inclusion/exclusion criteria for the medication component of the study but not the MRI portion will still be eligible to reenroll in and complete the medication/treatment phase.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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
Percent Days Abstinent	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 6 month follow up
Total Score of Relationship Functioning	Dyadic Adjustment Scale, a self-report survey, will be used to assess relationship functioning. Scores can range from 0 to 151, with a higher score indicating greater relationship functioning.	Baseline to 6 month follow up
Percent Days Heavy Drinking	Time Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days heavy drinking (5 or more days of binge drinking per month).	Baseline to 6 month follow up

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): September 30, 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): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Alcohol; Therapy; Couple
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• 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