Interpersonal Conflict, Neuroendocrine Reactivity, Substance Misuse
Conditions
Brief summary
Oxytocin is a promising new medication found to have positive effects on prosocial behavior, reduce negative affect such as fear and anxiety, and reduce stress-induced addictive behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal oxytocin improves couples' conflict resolution skills and subjective, physiological, and neuroendocrine responses to conflict. Conflict resolution discussions will take place in the laboratory and will be videotaped.
Detailed description
Substance use disorders (SUD) are characterized by dysregulation of the hypothalamic-pituitary axis (HPA). The neuropeptide oxytocin, commonly administered as an intranasal spray, is a drug that has prominent anxiolytic and prosocial effects on human behaviors. While the mechanisms of action facilitating the behavioral effects of oxytocin in humans is complex and many questions about this process remain, there is a consensus in the existing literature that oxytocin modulates HPA axis reactivity to stressful social stimuli. Preliminary studies suggest that oxytocin is known to reduce couple conflict among normative couples. A more developed line of research indicates that oxytocin mitigates addictive behaviors in the context of various drugs of abuse. Given the high prevalence and severity of dyadic conflict among couples where one or both partner has substance abuse, and given the salience of dyadic conflict as a precipitant to substance use behaviors, it is critical to investigate the therapeutic effects of oxytocin among couples with substance use problems. Namely, oxytocin holds promise as a potential augmenter for conjoint couples therapies, particularly those targeting the reduction of substance use problems. However, only two studies have examined the effects of oxytocin on couples' communication behaviors. Those two studies found that couples' communication skills improved following the administration of oxytocin. It is important to extend this line of research to examine conflict resolution skills among couples with substance use problems. To date, no studies have examined the effects of oxytocin on subjective, physiological, or neuroendocrine reactivity to dyadic conflict. The present study aims to fill that gap in the literature.
Interventions
DRUGOxytocin
DRUGPlacebo
Placebo for Oxytocin
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-65 years of age 2. both partners are willing to participate, and 3. at least one partner has engaged in hazardous drinking (i.e. 4 or more drinks for women, 6 or more for men) or illicit drug use during the past 60 days
Exclusion criteria
1. pregnancy for women 2. current psychotic or bipolar disorders 3. active suicidal or homicidal ideation and intent 4. subjects who would present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study 5. severe, unilateral intimate partner violence in the past year 6. BMI greater than 39.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frequency of Distress Maintaining Attributions | Frequency of distress maintaining attrbibutions per 10 minutes | Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Cortisol (μg/dL) | Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2. | Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.
Oxytocin | 32 |
| Placebo Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.
Placebo: Placebo for Oxytocin | 28 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo | Total | Oxytocin |
|---|---|---|---|
| Age, Continuous | 32.21 years STANDARD_DEVIATION 9.73 | 32.08 years STANDARD_DEVIATION 9.88 | 31.97 years STANDARD_DEVIATION 10.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Female | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 30 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 34 |
| other Total, other adverse events | 0 / 32 | 0 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 34 |
Outcome results
Primary
Change in Frequency of Distress Maintaining Attributions
Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions.
Time frame: Frequency of distress maintaining attrbibutions per 10 minutes
Population: Analyses were limited to heterosexual couples with reliable data reporting in order to accommodate the data analytic approach (i.e., multilevel modeling).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Change in Frequency of Distress Maintaining Attributions | .81 distress maintaining attributions | Standard Deviation 2.67 |
| Placebo | Change in Frequency of Distress Maintaining Attributions | -.48 distress maintaining attributions | Standard Deviation 2.51 |
Secondary
Change in Salivary Cortisol (μg/dL)
Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.
Time frame: Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2.
Population: Three couples (6 total participants) were not included in analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 3 (Post Conflict Discussion #1) | .18 μg/dL | Standard Deviation 0.11 |
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 5 (15 minutes Post Conflict Discussion) | .16 μg/dL | Standard Deviation 0.1 |
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 2 (Pre Conflict Discussion #1) | .25 μg/dL | Standard Deviation 0.14 |
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 6 (30 minutes Post Conflict Discussion) | .17 μg/dL | Standard Deviation 0.1 |
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 4 (Post Conflit Discussion #2) | .17 μg/dL | Standard Deviation 0.11 |
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 7 (60 Minutes Post Conflict Discussion) | .16 μg/dL | Standard Deviation 0.08 |
| Oxytocin | Change in Salivary Cortisol (μg/dL) | Time 1 (Baseline) | .28 μg/dL | Standard Deviation 0.18 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 7 (60 Minutes Post Conflict Discussion) | .19 μg/dL | Standard Deviation 0.13 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 1 (Baseline) | .30 μg/dL | Standard Deviation 0.2 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 2 (Pre Conflict Discussion #1) | .29 μg/dL | Standard Deviation 0.18 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 3 (Post Conflict Discussion #1) | .21 μg/dL | Standard Deviation 0.12 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 4 (Post Conflit Discussion #2) | .22 μg/dL | Standard Deviation 0.16 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 5 (15 minutes Post Conflict Discussion) | .22 μg/dL | Standard Deviation 0.2 |
| Placebo | Change in Salivary Cortisol (μg/dL) | Time 6 (30 minutes Post Conflict Discussion) | .22 μg/dL | Standard Deviation 0.18 |