Oxytocin, Alcohol Craving, and Intimate Partner Aggression

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Alcohol Use

Treatments: Drug: Placebo; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03046836

54689

Details and patient eligibility

About

Alcohol use disorders (AUD) and intimate partner aggression (IPA) frequently co-occur. There are significant health and economic burdens associated with AUD and co-occurring IPA, and little empirical data to guide treatment efforts. The neuropeptide oxytocin may help mitigate both AUD and IPA. However, clinical data examining oxytocin's effects on human aggression is scant. The proposed study is designed to address these gaps in the literature by utilizing a human laboratory paradigm to test the effects of oxytocin on craving and aggression among couples with AUD and co-occurring IPA.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria indicate that participants must
• aged 18 or over
• fluent in English
• endorse at least one instance of mild or moderate physical IPA with their partner in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2)
• both partners must be willing to participate
• one or both partners must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for an alcohol use disorder (AUD). Concurrent substance use disorders (e.g., marijuana) is acceptable provided alcohol is the participant's primary substance of choice.

Exclusion criteria

• Exclusion criteria include
• pregnancy or breastfeeding
• current or history of psychiatric or medical condition that could interfere with neuroendocrine function (e.g., hematological, endocrine, renal, or pulmonary disease; synthetic glucocorticoid or exogenous steroid therapy; psychotic, bipolar, eating disorders)
• Body Max Index (BMI) ≥ 39
• current suicidal ideation and intent
• severe physical or sexual IPA in the past six months as defined by the Conflict Tactics Scale (CTS-2)
• initiation of psychotropic medication in the past 4 weeks
• acute alcohol withdrawal as indicated by a score of 8 or greater on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

Each participant will self-administer 40 international units (IU) intranasal Oxytocin

Treatment:

Drug: Oxytocin

Control

Placebo Comparator group

Description:

Each participant will self-administer matching saline placebo

Treatment:

Drug: Placebo