Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Effects of Oxytocin on Alcohol Craving and Intimate Partner Aggression
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Oxytocin
Each participant will self-administer 40 international units (IU) intranasal Oxytocin
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40 IU oxytocin nasal spray
Autres noms:
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Comparateur placebo: Control
Each participant will self-administer matching saline placebo
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Saline
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Alcohol Craving
Délai: 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).
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Change in subjective alcohol craving as measured by a Visual Analogue Scale (VAS) between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a 100mm Likert-type scale from 0 (not at all/no craving) to 10 (extremely/maximum carving). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no craving and and highest value is a 10 (ten) representing extreme craving. |
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).
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Laboratory Intimate Partner Aggression Intensity (IPA)
Délai: 10 minutes from start to end of TAP
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Intensity of laboratory-based IPA was assessed using the Taylor Aggression Paradigm (TAP). IPA intensity is operationalized as the volume of "shock" administered on a 1-10 (1 is least intense, 10 is most intense) scale using the computer based paradigm in response to "losing" trials. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of "winning" or "losing" trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to "losing" trials. |
10 minutes from start to end of TAP
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Laboratory Intimate Partner Aggression (IPA) Duration
Délai: 10 minutes from start to end of TAP
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Laboratory IPA Duration was measured by the length of time participants administered "shocks" in the Taylor Aggression Paradigm (TAP). Measured in milliseconds. Greater number of milliseconds represents a longer shock. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of "winning" or "losing" trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to "losing" trials. |
10 minutes from start to end of TAP
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Cortisol
Délai: Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).
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Change in salivary cortisol measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) Higher salivary cortisol is indicative of higher stress response and lower salivary cortisol is indicative of lower stress response. |
Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).
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Change in Subjective Aggression
Délai: Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).
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Mean change in subjective aggression scores as measured by a Visual Analogue Scale (VAS) between time point 4 (after alcohol cue) and 5 (during Taylor Aggression Paradigm, TAP). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a Likert-type scale from 0 (not at all/no aggression) to 10 (extremely/maximum aggression). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no aggression and and highest value is a 10 (ten) representing extreme aggression. |
Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Julianne C Flanagan, Ph.D., Medical University of South Carolina
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 54689
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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