Status:
COMPLETED
Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Couples
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 functio...
Eligibility Criteria
Inclusion
- 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, or in a committed relationship for ≥ 6 months.
- 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.
- 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.
- 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.
- 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.
- Severe unilateral intimate partner violence in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2).
- Pregnancy or breastfeeding for women.
- 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.
Exclusion
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT03846505
Start Date
May 16 2019
End Date
January 31 2024
Last Update
February 21 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29401