Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
United States192 participantsStarted 2019-05-16
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)
Timeframe: Baseline to week 12
2
Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)
Timeframe: Baseline to week 12
3
Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)
. 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.