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Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

Primary Purpose

Alcohol Use Disorder, Couples

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Couple, Alcohol, Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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).

Secondary Outcome Measures

Full Information

First Posted
February 17, 2019
Last Updated
August 2, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03846505
Brief Title
Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
Official Title
Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Couples
Keywords
Couple, Alcohol, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Oxytocin and Therapy Placebo and Therapy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
Primary Outcome Measure Information:
Title
Percent Days Abstinent
Description
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).
Time Frame
Baseline to 6 month follow up
Title
Total Score of Relationship Functioning
Description
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.
Time Frame
Baseline to 6 month follow up
Title
Percent Days Heavy Drinking
Description
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).
Time Frame
Baseline to 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female; any race or ethnicity; aged 18-75 years. 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). Married, cohabiting for ≥ 6 months, or in a committed relationship of at least 1-year duration. ≥1 hazardous drinking episode in past 60 days by IP. 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. Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice. 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: 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. Participants who present a serious suicide risk or are likely to require hospitalization during the study. History of seizures and/or seizure disorder Severe unilateral intimate partner violence in the past 6 months as defined by the CTS-2. Pregnancy or breastfeeding 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. Any unstable or serious medical condition affecting the potential participants' ability to participate in the study 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julianne Flanagan, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

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