Clinical trial NCT03046836: Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Official title: Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use
Keywords: Couples
Oxytocin
Aggression
Alcohol
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Alcohol Craving
timeFrame: Participants completed the VAS at 8 timepoints. Outcome measure represents the change in VAS scores between time point 3 (before the alcohol cue) and 4 (after the alcohol cue).
measure: Laboratory Intimate Partner Aggression Intensity (IPA)
timeFrame: 10 minutes from start to end of TAP
measure: Laboratory Intimate Partner Aggression (IPA) Duration
timeFrame: 10 minutes from start to end of TAP
Secondary outcomes:
measure: Change in Cortisol
timeFrame: Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).
measure: Change in Subjective Aggression
timeFrame: Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Julianne C Flanagan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: