Oxytocin, Alcohol Craving, and Intimate Partner Aggression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2021-04-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcohol Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxytocin

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

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

40 IU oxytocin nasal spray

Control

Each participant will self-administer matching saline placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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Oxytocin

40 IU oxytocin nasal spray

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Other Intervention Names

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Pitocin

Eligibility Criteria

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Inclusion Criteria

* 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

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No