Phase 2
N=200
Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Alcohol Use
Bottom Line
View on ClinicalTrials.gov: NCT03046836 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Change in Alcohol Craving — 0.90; 1.21 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alcohol Craving |
0.90; 1.21 | — |
| PRIMARY Laboratory Intimate Partner Aggression Intensity (IPA) |
4.8; 4.3 | — |
| PRIMARY Laboratory Intimate Partner Aggression (IPA) Duration |
405.5; 414.4 | — |
| SECONDARY Change in Cortisol |
0.11; 0.11 | — |
| SECONDARY Change in Subjective Aggression |
0.31; 0.41 | — |
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).
Data sourced from ClinicalTrials.gov (NCT03046836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.